3,980 Regulatory Compliance jobs in the United States
Regulatory & Compliance Specialist
Posted 1 day ago
Job Viewed
Job Description
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Job Type: Full time
Job Title: Regulatory & Compliance Specialist
Location: Onsite - San Diego
Salary Range: $90,000 - $95,000
Position Summary:
The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. This role will work closely with cross-functional teams to support product development, manufacturing, and post-market activities. The specialist will ensure that all documentation and files related to diagnostic development are completed in a timely manner and are ready for inspections.
Key Responsibilities:
- Ensure compliance with regulatory requirements for In Vitro Diagnostic products, FDA 21 CFR Part 820, ISO 13485.
- Provide regulatory guidance during the product development process, ensuring that products are designed and developed in compliance with applicable regulations.
- Participate in risk management activities, including the development and maintenance of risk management files according to ISO 14971 and FDA 21 CFR Part 820.
- Conduct risk assessments and work with product development teams to mitigate identified risks.
- Participate in design reviews meetings and validation activities, ensuring that regulatory and quality requirements are met.
- Review and approve design control documentation, including design input and output, design verification and validation protocols, ensuring that all documentation meets regulatory requirements.
- Review and approve design history file for each new product.
- Support preparation of internal quality and regulatory documents in support of regulatory submission (De Novo and 510K) for IVD products.
- Education:
- Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs, Quality Management) or equivalent experience.
- Advanced degree or certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., CQE, CQA) is a plus.
- Experience:
- 3+ years of experience in regulatory affairs, quality assurance, or compliance within the medical device or In Vitro Diagnostics industry.
- Experience with regulatory submissions, including 510(k) and CE marking, is highly preferred.
- Strong knowledge of global regulatory standards, including FDA regulations and ISO 13485.
- Skills:
- Strong understanding of IVD product development and manufacturing processes.
- Excellent written and verbal communication skills
- Strong analytical and problem-solving skills, with attention to detail and accuracy.
- Ability to work independently and as part of a team, with strong organizational and time-management skills.
- High level of integrity and commitment to upholding regulatory and quality standards.
- Proactive approach to identifying and addressing compliance risks and issues.
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development
We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.
Regulatory Compliance Specialist
Posted 1 day ago
Job Viewed
Job Description
Hybrid : Full Time must live in one of 6 states: CA, AZ, NV, TX, WA, OR; remote and on site in Alameda County. Available for Full-Time Work Schedule 8:00am - 5pm Pacific Time, Monday-Friday. Hybrid positions work a minimum of up to_2_ days per week in Alameda Alliance for Health's office, located at _Alameda CA, and a minimum of three days per week remotely.
PRINCIPAL RESPONSIBILITIES :
Under the direction of the Supervisor, Regulatory Affairs & Compliance, the Regulatory Compliance Specialist supports the compliance program by coordinating implementation of new and revised healthcare rules and requirements as are communicated by state and federal agencies.
Principal responsibilities include:
*Read, review and summarize prospective, new and revised rules and healthcare policy from local, state and federal agencies, including but not limited to, the Department of Managed Health Care (DMHC), the Department of Health Care Services (DHCS), and Centers for Medicare & Medicaid Services (CMS).
*Coordinate with internal departments to gather data and information for regulatory submissions, including Medicare Advantage plan bids and formulary submissions
*Schedule and lead meetings with stakeholders to review analysis, discuss key points, next steps, and potential issues affecting implementation, including Medicare Advantage and Part D compliance requirements.
*Documents all actions taken by stakeholders to maintain a clear written record of the chronology of implementation for tracking and transparency.
*Assist with the completion of CMS, DMHC and DHCS submission, amendments and material modifications related to all policy preparation, implementation and execution, including Annual Notice of Change (ANOC) and Evidence of Coverage (EOC) documents for Medicare Advantage plans.
*Assist with internal information gathering as may be required during audits and other requests from state and federal agencies, including CMS program audits.
*Participate in and represent the Alliance at state agency and professional association meetings, trainings, conferences and webinars related to new regulatory mandates, regulatory updates, new member benefits and changes to existing member benefits, with a focus on Medicare Advantage and Part D programs.
*Participate in and represent the Compliance Department on internal committees and work groups related to prospective, new or revised legislation and policy work, including Medicare Advantage and Part D policy changes.
*Assist in coordinating state and federal audit visits and complete responses, including Medicare Advantage and Part D program audits.
*Assist in the implementation of audit processes to ensure compliance with federal and state statutes and regulations and program guidance, including Medicare Advantage and Part D requirements.
*Research questions from staff regarding regulatory compliance related to all products and business.
*Maintain knowledge of business products and related Alliance policies and procedures and alert the compliance staff of non-compliance risks, with emphasis on Medicare Advantage and Part D products.
*Distributes the Department of Managed Health Care (DMHC) and Department of Health Care Services (DHCS) All Plan Letters (APL), CMS Guidance and other regulatory policy guidance to internal stakeholders in a timely manner. This includes Medicare Advantage and Part D memoranda, guidance, and regulatory updates.
*Complete other special projects and duties as assigned, to include Medicare-related initiatives.
ESSENTIAL FUNCTIONS OF THE JOB
*Communicating effectively and efficiently internally and externally.
*Writing, reporting, researching, administration, and analysis.
*Developing verbal presentations.
*Leading and participating in internal and external committees and meetings.
*Complying with the organization's Code of Conduct, all regulatory and contractual requirements, organizational policies, procedures, and internal controls.
PHYSICAL REQUIREMENTS
*Constant and close visual work at desk or on a computer.
*Constant sitting and working at desk.
*Constant data entry using keyboard and/or mouse.
*Frequent use of telephone headset.
*Frequent verbal and written communication with staff and other business associates by telephone, correspondence, or in person.
*Frequent lifting of folders and various other objects weighing between 0 and 30 lbs.
*Frequent walking and standing.
Number of Employees Supervised: 0
MINIMUM QUALIFICATIONS:
EDUCATION OR TRAINING EQUIVALENT TO:
*Bachelor of Arts or Bachelor of Science degree required. Focus in related field, preferred.
*In lieu of degree, equivalent education and/or experience may be considered
*Familiarity with Medicaid (Medi-Cal), Medicare and other publicly funded programs.
*Familiarity with CMS, DHCS, DMHC rules and regulations.
MINIMUM YEARS OF ADDITIONAL RELATED EXPERIENCE:
*One-to-Three-year related experience in healthcare preferably in a managed care setting.
SPECIAL QUALIFICATIONS (SKILLS, ABILITIES, LICENSE):
*Experience with CMS reporting compliance for clients (CDAG/ODAG/ODR/CDE) preferred.
*Familiarity with Medicare Marketing Guidelines and materials development process, a plus.
*Understanding of Medicare risk adjustment methodologies and processes a plus.
*Understanding of federal and state regulatory bodies and processes.
*Proficiency in correct English usage, grammar, and punctuation.
*Ability to communicate effectively, both verbally and in writing.
*Exemplary interpersonal skills including ability to collaborate effectively as part of a team across organizational structure is a must.
*Ability to think critically, make informed decisions and work independently with minimal supervision.
*Excellent organizational skills and orientational to detail.
*Proven ability to prioritize and manage multiple projects simultaneously and meet deadlines.
*Experience in use of computer system software such as MS Word, Excel, Access, Outlook, SharePoint, and PowerPoint.
*Familiarity with Smartsheet and Team Dynamics (TDX), a plus.
*Familiarity with HPMS, DMHC E-filing/Timely Access Portal and DHCS Submission Processes, a plus.
SALARY RANGE $83,241.60 - $124,862.40
The Alliance is an equal opportunity employer and makes all employment decisions on the basis of merit and business necessity. We strive to have the best-qualified person in every job. The Alliance prohibits unlawful discrimination against any employee or applicant for employment based on race, color, religious creed, sex, gender, transgender status, age, sexual orientation, national origin, ethnicity, citizenship, ancestry, religion, marital status, familial status,status as a victim of domestic violence, assault or stalking, military service/veteran status, physical or mental disability, genetic information, medical condition, employees requesting accommodation of a disability or religious belief, political affiliation or activities, or any other status protected by federal, state, or local laws.
#J-18808-LjbffrRegulatory Compliance Specialist
Posted 3 days ago
Job Viewed
Job Description
Employment Type: Salaried
Work Arrangement: Remote
We are seeking a Regulatory Compliance Specialist to join our team of food regulatory professionals, to provide expertise in regulatory compliance, religious dietary laws and food labeling. This position will play a critical role in assessing compliance of food ingredients, food product formulations and finished food products, manufactured and distributed within United States, Canada and one of our global selling markets (e.g., APAC, EMEA or LATAM).
Major Duties and Responsibilities:- Performs country permissibility assessments on food ingredients, food product formulations and labeling of finished food products, in one of the global selling markets (e.g., APAC, EMEA or LATAM), to support international business initiatives.
- Executes the appropriate regulatory compliance services, in response to customers' requests and enquiries. This may cover allergens, biotechnology, claims, export certificates, food ingredients, food product formulations, finished food products, foreign food facility registrations, food laws and regulations, religious programs (Kosher and Halal) and other regulatory services.
- Reviews labels and packaging artwork designs, at each stage in the food product development and commercialization processes and provide guidance to ensure labeling compliance under CFIA, FDA, USDA and other global Food Regulatory Agencies.
- Works cross-functionally and collaboratively on projects covering existing and new food product development, commercial launches, new and existing food laws and regulations. The projects may include new and existing food ingredients, food and color additives, nutrition, claims and food labeling.
- Facilitates regulatory training programs, performs peer review assessments and writes Standard Operating Procedures, One Point Lessons, guides and other written instructions, to facilitate knowledge transfer and enhance regulatory capability and capacity.
- Additional responsibilities as assigned.
- Bachelor of Science Degree in Food Science, Food Nutrition, International Food law, or related field required.
- A minimum of three (3) years' experience within the food industry, in regulatory compliance, or in a regulatory affairs capacity required.
- Demonstrative past performances of successful implementation and execution of food labeling programs and religious food manufacturing certifications required.
- Equivalent food industry experience with progressive career advancement opportunities within the food regulatory field preferred.
- Experience working in a collaborative and team-based environment preferred.
- International Food Law, Regulatory Compliance or Food Law certification preferred.
- In-depth knowledge in the relevant food laws and regulations governing CFIA, FDA and USDA jurisdictions.
- A working knowledge of food laws and regulations in APAC, EMEA and LATAM geographical regions.
- Proficient knowledge of Microsoft Office, FoodChain ID Regulatory Library, FoodChain ID Regulatory Assessment and Genesis R&D Food Formulation & Labeling Software.
- Knowledgeable in hazard analysis, risk assessments, food safety concepts and food labeling verification program.
- Demonstrative understanding of Code of Federal Regulations (CFR), Food Safety Modernization Act (FSMA) and associated Final Rules, Federal Food Drug and Cosmetic Act (FFDCA), Codex Alimentarius, United States Department of Agriculture (USDA) labeling statutes and regulations and other applicable regulations governing food manufacturing.
- Highly motivated, collaborative, self-directed and self-starter team player.
- Excellent organizational, communications (both verbal and written), interpersonal and team interaction skills.
- Apt at interpreting and communicating food laws and regulations and developing strategies to ensure global compliance.
Why Join Us:
Ventura Foods innovates and manufactures food solutions for foodservice and retail businesses. We make exclusive products for the world's most iconic restaurants and retailers, we provideready-to-goproduct solutions for professional kitchens, and we make consumer brands everyone knows and loves.When you work for Ventura Foods, you get a strong foundation of training, a manager who cares about you and celebrates your success, a safe environment, and challenging work.As part of our team, your future is limited only by how much you're willing to push yourself to get there. We invest in your growth because you invest in ours.
Ventura Foods offers career growth opportunities as well as competitive compensation and benefits:
- Medical, Prescription, Dental, & Vision - coverage beginning on your 1st day for eligible employees
- Profit Sharing and 401(k) matching (after eligible criteria is met)
- Paid Vacation, Sick Time, and Holidays
- Employee Appreciation Events and Employee Assistance Programs
- Salary Base Range of $57,560.50-$87,392.97*
*The "base salary range" provided above is a good faith estimate of what we expect to pay for this position in the specified markets. Ventura Foods reserves the right to pay outside of the given range based on a variety of factors including but not limited to: candidate skills and experience, complexity of the job, budgetary factors, and location/geography. Ventura Foods conducts regular reviews of compensation ranges and therefore reserves the right to alter this range at any given time.
Diversity & Inclusion:
Our commitment to a diverse and inclusive environment in which all employees are treated with respect is evident in our company culture and values. We believe that fostering an environment of inclusion and a focus on diversity across our organization is vital to attracting top talent, driving innovation, and meeting the high expectations of our customers in a rapidly evolving global marketplace.
Ventura Foods is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.
#J-18808-LjbffrRegulatory Compliance Specialist
Posted 9 days ago
Job Viewed
Job Description
Regulatory Compliance Specialist / Req 822408492 (Manufacturing)
Regulatory Compliance Specialist / Req 822408492 (Manufacturing)
Remote: Full Time must live in one of 6 states where we operate: CA, AZ, NV, TX, WA, OR. Available for Full-Time Work Schedule 8:00am - 5pm Pacific Time, Monday-Friday.PRINCIPAL RESPONSIBILITIES:
Under the direction of the Supervisor, Regulatory Affairs & Compliance, the Regulatory Compliance Specialist supports the compliance program by coordinating implementation of new and revised healthcare rules and requirements as are communicated by state and federal agencies.
Principal responsibilities include:
Read, review and summarize prospective, new and revised rules and healthcare policy from local, state and federal agencies, including but not limited to, the Department of Managed Health Care (DMHC), the Department of Health Care Services (DHCS), and Centers for Medicare & Medicaid Services (CMS).
Coordinate with internal departments to gather data and information for regulatory submissions, including Medicare Advantage plan bids and formulary submissions
Schedule and lead meetings with stakeholders to review analysis, discuss key points, next steps, and potential issues affecting implementation, including Medicare Advantage and Part D compliance requirements.
Documents all actions taken by stakeholders to maintain a clear written record of the chronology of implementation for tracking and transparency.
Assist with the completion of CMS, DMHC and DHCS submission, amendments and material modifications related to all policy preparation, implementation and execution, including Annual Notice of Change (ANOC) and Evidence of Coverage (EOC) documents for Medicare Advantage plans.
Assist with internal information gathering as may be required during audits and other requests from state and federal agencies, including CMS program audits.
Participate in and represent the Alliance at state agency and professional association meetings, trainings, conferences and webinars related to new regulatory mandates, regulatory updates, new member benefits and changes to existing member benefits, with a focus on Medicare Advantage and Part D programs.
Participate in and represent the Compliance Department on internal committees and work groups related to prospective, new or revised legislation and policy work, including Medicare Advantage and Part D policy changes.
Assist in coordinating state and federal audit visits and complete responses, including Medicare Advantage and Part D program audits.
Assist in the implementation of audit processes to ensure compliance with federal and state statutes and regulations and program guidance, including Medicare Advantage and Part D requirements.
Research questions from staff regarding regulatory compliance related to all products and business.
Maintain knowledge of business products and related Alliance policies and procedures and alert the compliance staff of non-compliance risks, with emphasis on Medicare Advantage and Part D products.
Distributes the Department of Managed Health Care (DMHC) and Department of Health Care Services (DHCS) All Plan Letters (APL), CMS Guidance and other regulatory policy guidance to internal stakeholders in a timely manner. This includes Medicare Advantage and Part D memoranda, guidance, and regulatory updates.
Complete other special projects and duties as assigned, to include Medicare-related initiatives.
ESSENTIAL FUNCTIONS OF THE JOB
Communicating effectively and efficiently internally and externally.
Writing, reporting, researching, administration, and analysis.
Developing verbal presentations.
Leading and participating in internal and external committees and meetings.
Complying with the organizations Code of Conduct, all regulatory and contractual requirements, organizational policies, procedures, and internal controls.
PHYSICAL REQUIREMENTS
Constant and close visual work at desk or on a computer.
Constant sitting and working at desk.
Constant data entry using keyboard and/or mouse.
Frequent use of telephone headset.
Frequent verbal and written communication with staff and other business associates by telephone, correspondence, or in person.
Frequent lifting of folders and various other objects weighing between 0 and 30 lbs.
Frequent walking and standing.
Number of Employees Supervised: 0
MINIMUM QUALIFICATIONS:
EDUCATION OR TRAINING EQUIVALENT TO:
Bachelor of Arts or Bachelor of Science degree required. Focus in related field, preferred.
In lieu of degree, equivalent education and/or experience may be considered
Familiarity with Medicaid (Medi-Cal), Medicare and other publicly funded programs.
Familiarity with CMS, DHCS, DMHC rules and regulations.
MINIMUM YEARS OF ADDITIONAL RELATED EXPERIENCE:
One-to-Three-year related experience in healthcare preferably in a managed care setting.
SPECIAL QUALIFICATIONS (SKILLS, ABILITIES, LICENSE):
Experience with CMS reporting compliance for clients (CDAG/ODAG/ODR/CDE) preferred.
Familiarity with Medicare Marketing Guidelines and materials development process, a plus.
Understanding of Medicare risk adjustment methodologies and processes a plus.
Understanding of federal and state regulatory bodies and processes.
Proficiency in correct English usage, grammar, and punctuation.
Ability to communicate effectively, both verbally and in writing.
Exemplary interpersonal skills including ability to collaborate effectively as part of a team across organizational structure is a must.
Ability to think critically, make informed decisions and work independently with minimal supervision.
Excellent organizational skills and orientational to detail.
Proven ability to prioritize and manage multiple projects simultaneously and meet deadlines.
Experience in use of computer system software such as MS Word, Excel, Access, Outlook, SharePoint, and PowerPoint.
Familiarity with Smartsheet and Team Dynamics (TDX), a plus.
Familiarity with HPMS, DMHC E-filing/Timely Access Portal and DHCS Submission Processes, a plus.
SALARY RANGE $83,241.60 - $124,862.40
The Alliance is an equal opportunity employer and makes all employment decisions on the basis of merit and business necessity. We strive to have the best-qualified person in every job. The Alliance prohibits unlawful discrimination against any employee or applicant for employment based on race, color, religious creed, sex, gender, transgender status, age, sexual orientation, national origin, ethnicity, citizenship, ancestry, religion, marital status, familial status,status as a victim of domestic violence, assault or stalking, military service/veteran status, physical or mental disability, genetic information, medical condition, employees requesting accommodation of a disability or religious belief, political affiliation or activities, or any other status protected by federal, state, or local laws.
Regulatory & Compliance Specialist
Posted 20 days ago
Job Viewed
Job Description
Who is CorDx?
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Job Type: Full time
Job Title: Regulatory & Compliance Specialist
Location: Onsite - San Diego
Salary Range: $90,000 - $95,000
Position Summary:
The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. This role will work closely with cross-functional teams to support product development, manufacturing, and post-market activities. The specialist will ensure that all documentation and files related to diagnostic development are completed in a timely manner and are ready for inspections.
Key Responsibilities:
- Ensure compliance with regulatory requirements for In Vitro Diagnostic products, FDA 21 CFR Part 820, ISO 13485.
- Provide regulatory guidance during the product development process, ensuring that products are designed and developed in compliance with applicable regulations.
- Participate in risk management activities, including the development and maintenance of risk management files according to ISO 14971 and FDA 21 CFR Part 820.
- Conduct risk assessments and work with product development teams to mitigate identified risks.
- Participate in design reviews meetings and validation activities, ensuring that regulatory and quality requirements are met.
- Review and approve design control documentation, including design input and output, design verification and validation protocols, ensuring that all documentation meets regulatory requirements.
- Review and approve design history file for each new product.
- Support preparation of internal quality and regulatory documents in support of regulatory submission (De Novo and 510K) for IVD products.
Requirements
- Education:
- Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs, Quality Management) or equivalent experience.
- Advanced degree or certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., CQE, CQA) is a plus.
- Experience:
- 3+ years of experience in regulatory affairs, quality assurance, or compliance within the medical device or In Vitro Diagnostics industry.
- Experience with regulatory submissions, including 510(k) and CE marking, is highly preferred.
- Strong knowledge of global regulatory standards, including FDA regulations and ISO 13485.
- Skills:
- Strong understanding of IVD product development and manufacturing processes.
- Excellent written and verbal communication skills
- Strong analytical and problem-solving skills, with attention to detail and accuracy.
- Ability to work independently and as part of a team, with strong organizational and time-management skills.
- High level of integrity and commitment to upholding regulatory and quality standards.
- Proactive approach to identifying and addressing compliance risks and issues.
Benefits
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development
We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.
Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
Job Summary: Talent Software Services is in search of a Regulatory Compliance Specialist for a contract position in Allentown, PA. The opportunity will be six months with a strong chance for a long-term extension.
Position Summary: This position involves managing and administering the day-to-day implementation of Universal Service Programs in accordance with regulatory requirements. The role requires negotiating contracts with Community-Based Organizations (CBOs) that implement programs designed to assist low-income and payment-troubled customers. The position also entails managing and providing training to the CBO caseworker workforce, assisting in the implementation and negotiation of contracts for PUC-required programs for low-income customers, and coordinating the daily activities of regional bargaining unit personnel. The role requires training and monitoring contractors and CBO caseworkers delivering USP services and achieving expenditure and performance goals associated with Commission-required programs.
Primary Responsibilities/Accountabilities:
- Directs the implementation and communication of energy conservation programs and customer assistance programs that meet customer needs, company expectations, and PUC regulations.
- Evaluates performance standards of community-based organizations and contractors for PUC reporting requirements, meeting department goals, and ensuring quality programs.
- Works with CBOs and internal support staff to achieve the implementation of PUC-required US Government Client and expenditures.
- Assists in the development of marketing initiatives to effectively promote the USP programs and identifies and implements system process requirements to support regulatory tracking and reporting requirements.
- Establishes and maintains strong relationships with community leaders, community-based organizations, and internal departments to ensure the effective implementation of USP programs.
- Supports the timely and accurate completion of various PUC-required reports and assists in preparing internal ad hoc reports.
- May be assigned an Electric Utilities emergency and storm role, necessitating work after-hours during emergencies.
- Bachelor's Degree or 7 years of equivalent experience in customer service, energy-related products management, or human service program delivery.
- Five years of experience working in the electric utility industry, energy efficiency providers, or community-based organizations.
- Experience in implementing programs and services for low-income families.
- Bachelor's or master's degree in business, communications, marketing, or a technical discipline.
- Ten years of experience in the electric utility industry, energy efficiency providers, or community-based organizations.
- Solid writing, oral communications, and analytical skills.
- Experience in vendor performance management and managing budgets.
- Proficiency in Microsoft products such as Word and Excel.
- Ability to work well with individuals at all levels of related internal and external organizations and adapt to change.
If this job is a match for your background, we would be honored to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk!
Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
EControls is a global provider of innovative, state-of-the-art integrated controls solutions for internal combustion engines and electric drive systems in the off-highway, on-highway, and stationary equipment markets. EControls designs world-class, full-authority engine management systems for major OEMs around the world. Our global engine development labs and engineering staff offer full-range support, from design guidance for base engine conversion to hardware, software, and engine calibration to meet each application's specific requirements.
We are passionate about customer satisfaction and service. We fearlessly engage in any effort that will eliminate our customers' risk and clear a path to their success. We immerse ourselves in our customers' world, reveal unknowns and deliver integrated solutions.
We are seeking a detail-oriented and proactive Regulatory Compliance Specialist to join our Quality & Compliance team. In this role, you will be instrumental in ensuring our products meet regulatory standards and certification requirements across key global markets. Your work will support third-party compliance, quality documentation, and product certifications for a diverse range of product lines.
Key Responsibilities:
- UL and CSA Compliance:
- Support regulatory compliance efforts related to UL and CSA standards.
- Coordinate third-party factory audits and follow up on corrective actions to address audit findings and resolve variations.
- AGA and ECE e4 Certification:
- Plan, schedule, and support product testing in alignment with AGA and ECE e4 regulatory requirements.
- Maintain communication with testing laboratories and certification bodies to ensure smooth and timely compliance processes.
- Quality Record Management:
- Manage and maintain product certification records and compliance documentation in a controlled Quality Record system.
- Ensure documentation accuracy and support internal and external audits.
Qualifications:
- Highschool degree required.
- Associates degree or Bachelor's degree in Engineering, Quality, Regulatory Affairs, or a related field preferred.
- 2+ years of experience in regulatory compliance, quality assurance, or certification coordination.
- Familiarity with UL, CSA, AGA, and ECE e4 certification processes.
- Strong organizational and documentation skills.
- General knowledge of engine components preferred
- Experienced with Microsoft Office Tools - Excel, Work, and Qutlook.
- Experience working with engineering design and test standards.
- Proficiency with document control platforms.
- Excellent communication skills and ability to work cross-functionally.
- Detail-oriented with the ability to manage multiple projects and deadlines.
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Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
Job DescriptionJob DescriptionEControls is a global provider of innovative, state-of-the-art integrated controls solutions for internal combustion engines and electric drive systems in the off-highway, on-highway, and stationary equipment markets. EControls designs world-class, full-authority engine management systems for major OEMs around the world. Our global engine development labs and engineering staff offer full-range support, from design guidance for base engine conversion to hardware, software, and engine calibration to meet each application's specific requirements.
We are passionate about customer satisfaction and service. We fearlessly engage in any effort that will eliminate our customers’ risk and clear a path to their success. We immerse ourselves in our customers’ world, reveal unknowns and deliver integrated solutions.
We are seeking a detail-oriented and proactive Regulatory Compliance Specialist to join our Quality & Compliance team. In this role, you will be instrumental in ensuring our products meet regulatory standards and certification requirements across key global markets. Your work will support third-party compliance, quality documentation, and product certifications for a diverse range of product lines.
Key Responsibilities:
- UL and CSA Compliance:
- Support regulatory compliance efforts related to UL and CSA standards.
- Coordinate third-party factory audits and follow up on corrective actions to address audit findings and resolve variations.
- AGA and ECE e4 Certification:
- Plan, schedule, and support product testing in alignment with AGA and ECE e4 regulatory requirements.
- Maintain communication with testing laboratories and certification bodies to ensure smooth and timely compliance processes.
- Quality Record Management:
- Manage and maintain product certification records and compliance documentation in a controlled Quality Record system.
- Ensure documentation accuracy and support internal and external audits.
Qualifications:
- Highschool degree required.
- Associates degree or Bachelor’s degree in Engineering, Quality, Regulatory Affairs, or a related field .
- 2+ years of experience in regulatory compliance, quality assurance, or certification coordination.
- Familiarity with UL, CSA, AGA, and ECE e4 certification processes.
- Strong organizational and documentation skills.
- General knowledge of engine components
- Experienced with Microsoft Office Tools – Excel, Work, and Qutlook.
- Experience working with engineering design and test standards.
- Proficiency with document control platforms.
- Excellent communication skills and ability to work cross-functionally.
- Detail-oriented with the ability to manage multiple projects and deadlines.
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Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
Level
Experienced
Job Location
Richland Goethals - Richland, WA
Secondary Job Location(s)
Lynnwood 188th St SW - Lynnwood, WA; Spokane Valley East Sprague - Spokane Valley, WA
Position Type
Full Time - Hourly
Education Level
4 Year Degree
Salary Range
$24.34 - $1.17 Hourly
Job Shift
Day
Description
Take a leap and join our team!
At Gesa, we believe in the power of our people. Coming from all walks of life, our team members' individual stories and unique experiences are our most valuable asset. But it's how we come together, igniting our collective compassion and commitment to empowering our communities, that makes us succeed. Because we know we go further when we go together.
Here you can join a team who is passionate about serving others, has a desire to do good, and shares a deep love of people. You can engage in meaningful work that impacts your community. You can challenge yourself and grow in your career. And, you can rest assured that your wellbeing and prosperity are our priority.
Get to know us: About - Gesa Credit Union
Role Summary:
Compliance Specialist role requires knowledge of consumer regulatory compliance and is responsible for monitoring and assessing adherence to all local, state, and federal regulations, including those applicable to mortgage loans, consumer loans, commercial lending, deposit products, commercial products, and various digital products and services. This position has autonomy of independent decision making within their areas of responsibility.
What You Will Be Doing:
- Knowledge and expertise in consumer and mortgage lending areas, specifically Regulation C (HMDA), Truth in Lending Act (Regulation Z), Real Estate Settlement Procedures Act (RESPA), Mortgage Servicing, Fair Credit Reporting Act, and Fair Lending regulations (ECOA and Fair Housing Act), SAFE Act, Flood Disaster Protection Act, Fair Debt Collection Practices Act, and Home Owners Protection Act
- Knowledge of credit union lending processes and procedures which must include experience with origination and servicing in at least one of the following areas: consumer lending, mortgage lending or commercial lending
- Knowledge of loan origination systems and ability to navigate the credit union's core processing systems
- Work with AVP of Compliance to perform extensive and complex validation and targeted reviews of lending HMDA data across consumer and business channels to ensure the data is collected and reported in compliance with the regulatory interpretation
- Research and assist in the analysis, interpretation, and application of lending regulations and practices as they relate to the credit union
- Work with AVP of Compliance to perform ongoing reviews of the credit union's loan products and work with the appropriate departments to analyze loan data for fair lending compliance
- Recommend policies, procedures, and processes to help ensure activities are conducted in compliance with applicable laws, regulations and rules
- Assist with review of third-party vendors to perform certain compliance audits following a Request for Proposal (RFP) process to detail the scope and price of the audits and recommend the selection of these vendors to conduct compliance audits/reviews
- Develop and conduct internal compliance self-assessments and internal reviews to ensure activities are conducted in compliance with applicable laws, regulations, and rules. Communicate the review requirements to appropriate departments, assist in collecting audit material as appropriate, and track all findings and resolutions
- Assist with performing and completing the credit union's regulatory risk assessment covering all consumer regulatory related risks, identify the gaps, and provide recommended solutions for the identified gaps. Work with the departmental stakeholders to implement those solutions
- Perform monitoring of vendor compliance with consumer regulations, deposit disclosure updates and tracking, compliance monitoring, quality control, and other compliance programs and projects as assigned
- Review the implementation of new products/services or changes to existing product/services for compliance and regulatory requirements and/or for potential issues and implement appropriate compliance validation steps
- Assist in the review of marketing materials for compliance with applicable state and federal laws prior to their release to the membership, when applicable
- Assist with periodic reports to AVP of Compliance for reporting to the Board of Directors, Supervisory Committee, and Executive Leadership with regards to compliance matters, when applicable
- Assist AVP of Compliance with performing compliance due diligence reviews for the vendor onboarding
- Keep abreast of changes in regulations as appropriate. Distribute appropriate materials to departments, assess progress on compliance with new regulations, and serve as a subject matter expert to the credit union on compliance related issues
- Maintain a continuous study of applicable State and Federal laws
- Advise supervisor of potential impact of new or amended regulations including those that affect mortgage, consumer loans, consumer and commercial accounts, and member privacy regulations
- Keep supervisor informed of key operating issues affecting areas of responsibility
- Participate and act as a subject matter expert with various cross-department projects involving change in products and/or new product release
- Act as compliance resource for the credit union including consumer deposit and loan regulations and mortgage regulations, including research, analysis, interpretation, and providing answers to consumer regulatory issues from all departments. Assist with training as requested
- Assist in evaluating and resolving member complaints related to regulatory compliance
- Perform other job-related duties as assigned by AVP of Compliance
- Perform all duties and maintain all sensitive data with the highest standard of confidentiality and professionalism. Consistently display respect for all areas of diversity and levels of knowledge
- Display leadership values such as mutual respect, trust, honesty and dignity, and act in the best interest of the credit union. Lead by example by displaying solid ethics and integrity at all times
- Control risk and operate in a safe and sound manner
- Perform administrative support as necessary for completion of tasks assigned
- Perform a variety of routine daily tasks; review reports and prepare correspondence; prepare periodic reports on the status of work activities; monitor compliance activities and reports with respect to areas of assigned responsibilities
- Assist VP of Internal Audit and/or delegate with state and federal compliance audits and examinations as needed
- Understanding of methodologies for researching and analyzing compliance issues
- Ability to assess regulatory requirements and assess successful completion of those requirements
- Ability to develop an expertise in certain regulatory areas, such as mortgage lending, consumer lending, etc.
- Understand money laundering and fraud scenarios and analyze account activity in light of potential illegal AML activity. Construct thorough and logical written analysis of account activity
- Excellent interpersonal and teamwork skills. Excellent listening skills and customer service attributes
- Proficient in computer applications, reporting, and file/data systems
- Problem-solving skills, detailed oriented, resourceful, process improvement know-how, and ability to express ideas
What You Will Need:
- BS/BA degree may be waived for a lesser degree based on years' experience in a qualified field, such asbanking, regulatory compliance, business management, electronic payments, projectmanagement, risk management,internal audit, or other analytical area
- Six(6) years or moreexperience in banking, regulatory compliance, business management, electronic payments, projectmanagement, risk management,internal audit, or another analytical field
- Credit Union Compliance Expert (CUCE) or other related compliance certifications is required. Additional lending certifications are preferred
- A solid understanding of a variety of consumer regulatory requirement
- Knowledge of concepts, practices, and compliance techniques for the credit union industry
- Organizational and project management capabilities
- Ability to understand and analyze complex legal and regulatory issues and laws and provide compliance recommendations
- Understanding of reporting requirements of regulatory agencies relevant to assigned tasks
- Good communication skills, both written and oral. Courtesy, tact, and diplomacy to be exercised while giving or obtaining information, building relationships, or dealing with staff and members
- Some travel required to complete credit union training, assist in training other staff, or approved professional training
Our Team Member Value Proposition:
In exchange for bringing your talent to Gesa, here are a just a few of the benefits and perks we offer:
- Competitive Pay
- Medical, Dental, Vision, and Life Insurance
- 20 days/year of Paid Time Off - Plus 10 Paid Holidays!
- 401(k) Match
- Incentive Program
- Tuition Assistance and Student Loan Repayment
- Commuter Benefits
- Paid Time Off to Volunteer in the Community
- Product discounts
- Engaging Work Environment
- Rewards and Recognition Programs
Salary Range:
24.34 - 41.17
Get wise to what's possible with a career at Gesa. Join us!
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact the HR Department at ( or to request an accommodation.
Gesa Credit Union reserves the right to revise or change the job description as the need arises. This job description is not all inclusive of total job responsibilities nor does it constitute a written or implied contract of employment.
Selected candidate(s) must be able to pass a pre-employment credit/background check.
Gesa Credit Union is an Equal Opportunity Employer and strong advocate of workforce diversity. Race/Color/Gender/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Veteran.
Equal Employment Opportunity (gesa.com)
Regulatory Compliance Specialist
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Job Description
The Tulane Human Research Protection Office (HRPO) administers the University's Human Research Protection Program (HRPP) and Institutional Review Boards (IRBs), which are charged with reviewing and monitoring human subjects' research under the auspices of the University. The employee in this position participates in all aspects of IRB communication and database management, paper and electronic file management, meeting preparation and post meeting activities. The employee supports the research community with IRB protocol submissions and the use of IRB forms.
- Knowledge of current FDA, OHRP regulations for clinical research and related to IRB; or ability to learn these regulations
- Ability to demonstrate administrative skills
- Ability to be motivated and able to work in a high volume office
- Excellent written and oral communication skills
- Excellent customer service skills
- Knowledge of Windows-based applications
- Ability to be highly organized and detailed-oriented
- High level of interpersonal skills
- Project management skills
- Ability to work independently
- Bachelor's degree and two years of experience related to IRB issues and human subjects research protection, ethics, clinical trial performance, industry, and/or experience in a clinical field/setting
- High School or equivalent with 6 years of related experience
- Certified IRB Professional (CIP certification is highly desirable or will be required once eligible)