991 Government Regulations jobs in the United States
Government Regulations Coordinator, Ford at BlueOval City
Posted 5 days ago
Job Viewed
Job Description
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, we're all a part of something bigger than ourselves. Are you ready to change the way the world moves?
Ford's legacy of innovation is about to reach new heights. Imagine being on the ground floor of something truly extraordinary. At Ford at BlueOval City, Tennessee Electric Vehicle Center, we're not just assembling vehicles; we're leading a transformation. As a key member of our start-up team, you'll have a once-in-a-lifetime opportunity to launch a state-of-the-art manufacturing facility from the ground up. Imagine: you, at the forefront of the electrification movement, helping to bring the next generation of vehicles to driveways, job sites and highways everywhere.
At Ford at BlueOval City, Tennessee Electric Vehicle Center, you will.
• use your entrepreneurial skills and team mindset to come up with data-driven solutions
• build and lead an agile team to deliver the advanced technology that drives the future
• create a culture of trust, encourage diversity of thought and foster leadership in others
• be part of the historic transformation of the automotive industry.
The Government Regulations Coordinator (GRC) ensures the Tennessee Electric Vehicle Center (TEVC) complies with government regulations and quality standards. This role oversees vehicle certification, audits, and production compliance to meet safety and emissions requirements. Responsibilities include regulatory compliance, quality assurance, audit validation and supporting vehicle certification, conformity of production (COP), and government audits.
Responsibilities
Regulatory Compliance & Audits:
- Oversee QLS Campaign input and manage vehicle yard locations for quality holds, launch holds, engineering holds, and stop ships.
- Conduct required audits and report findings to plant management.
- Cooperate with Corporate Fresh Eye reviews and lead local validation audits.
- Represent the plant during government inspections, regulatory audits, and compliance reviews.
- Assist with NHTSA investigations, coordinating necessary requests.
- Manage external audits to ensure regulatory compliance and industry standards (e.g., ISO 9001).
- Maintain COP Control plans for non-self-certifying markets.
- Review Ford Automotive Procedures (FAP) and ensure plant compliance with established standards.
- Collaborate with internal teams to implement corrective actions generated from audits.
- Conduct vehicle audits to ensure emission and certification compliance.
- Engage in daily and weekly quality meetings to address concerns and drive improvements.
- Oversee error-proofing processes and manage torque audits for production accuracy.
- Validate compliance with windshield primer application, sealer expiration monitoring, material traceability, and any other requirements.
- Ensure proper VIN stamping for and traceability for body, engine, and transmission components.
- Perform security audits on VIN Plates and certification labels to prevent discrepancies.
- Supervise required fluid testing and ensure adherence to regulatory requirements.
- Work closely with engineering and production teams to resolve compliance-related concerns.
- Ensure FMVSS/CMVSS inspection items are recorded in QLS.
- Participate in new model launch meetings and monitor regulatory validation.
- Help update NAVIS to reflect compliance requirements.
- Verify emission certification documents.
- Ensure compliance with electric vehicle (EV) regulations, including battery safety, charging requirements, and any other initiatives.
- Monitor evolving government policies and recommend necessary adjustments.
- Oversee EV-specific regulatory audits and ensure compliance with international standards.
- Train new Supervisors/Managers on FMVSS requirements.
- Develop and coordinate backup training for GRC hourly staff.
You'll Have.
- Bachelor's degree in Engineering, Quality Assurance, or a related field, or equivalent experience.
- 3+ years of experience in manufacturing quality, vehicle regulations, or audit processes.
- Strong knowledge of government vehicle regulations, emission standards, and certification requirements.
- Ability to lead cross-functional teams in regulatory compliance initiatives.
- Experience with QLS, MCIR, and GSPAS audits.
- Proficiency in data analysis tools for compliance tracking and reporting.
- Ability to analyze data, generate reports, and implement corrective action plans.
- Excellent communication skills for coordinating audits, managing compliance records, and working with regulatory agencies.
- Highly organized, detail-oriented, and proficient in documentation management.
- Motivated high achiever with a proactive approach to compliance concerns.
- Willing to take ownership and responsibility for regulatory processes and audits.
- Big-picture thinker who drives long-term goals and continuous improvement.
You may not check every box, or your experience may look a little different from what we've outlined, but if you think you can bring value to Ford Motor Company, we encourage you to apply!
As an established global company, we offer the benefit of choice. You can choose what your Ford future will look like: will your story span the globe, or keep you close to home? Will your career be a deep dive into what you love, or a series of new teams and new skills? Will you be a leader, a changemaker, a technical expert, a culture builder.or all of the above? No matter what you choose, we offer a work life that works for you, including:
• Immediate medical, dental, vision and prescription drug coverage
• Flexible family care days, paid parental leave, new parent ramp-up programs, subsidized back-up child care and more
• Family building benefits including adoption and surrogacy expense reimbursement, fertility treatments, and more
• Vehicle discount program for employees and family members and management leases
• Tuition assistance
• Established and active employee resource groups
• Paid time off for individual and team community service
• A generous schedule of paid holidays, including the week between Christmas and New Year's Day
• Paid time off and the option to purchase additional vacation time.
This position is a leadership level 6.
For more information on salary and benefits, click here:
Visa sponsorship is available for this position.
Candidates for positions with Ford Motor Company must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status. In the United States, if you need a reasonable accommodation for the online application process due to a disability, please call 1- .
#LI-Onsite #LI-OG1
Government Regulations Coordinator, Ford at BlueOval City
Posted 8 days ago
Job Viewed
Job Description
Ford's legacy of innovation is about to reach new heights. Imagine being on the ground floor of something truly extraordinary. At Ford at BlueOval City, Tennessee Electric Vehicle Center, we're not just assembling vehicles; we're leading a transformation. As a key member of our start-up team, you'll have a once-in-a-lifetime opportunity to launch a state-of-the-art manufacturing facility from the ground up. Imagine: you, at the forefront of the electrification movement, helping to bring the next generation of vehicles to driveways, job sites and highways everywhere.
At Ford at BlueOval City, Tennessee Electric Vehicle Center, you will.
- use your entrepreneurial skills and team mindset to come up with data-driven solutions
- build and lead an agile team to deliver the advanced technology that drives the future
- create a culture of trust, encourage diversity of thought and foster leadership in others
- be part of the historic transformation of the automotive industry.
The Government Regulations Coordinator (GRC) ensures the Tennessee Electric Vehicle Center (TEVC) complies with government regulations and quality standards. This role oversees vehicle certification, audits, and production compliance to meet safety and emissions requirements. Responsibilities include regulatory compliance, quality assurance, audit validation and supporting vehicle certification, conformity of production (COP), and government audits.
Regulatory Compliance & Audits:
+ Oversee QLS Campaign input and manage vehicle yard locations for quality holds, launch holds, engineering holds, and stop ships.
+ Conduct required audits and report findings to plant management.
+ Cooperate with Corporate Fresh Eye reviews and lead local validation audits.
+ Represent the plant during government inspections, regulatory audits, and compliance reviews.
+ Assist with NHTSA investigations, coordinating necessary requests.
+ Manage external audits to ensure regulatory compliance and industry standards (e.g., ISO 9001).
+ Maintain COP Control plans for non-self-certifying markets.
+ Review Ford Automotive Procedures (FAP) and ensure plant compliance with established standards.
+ Collaborate with internal teams to implement corrective actions generated from audits.
Quality Assurance & Plant Operations:
+ Conduct vehicle audits to ensure emission and certification compliance.
+ Engage in daily and weekly quality meetings to address concerns and drive improvements.
+ Oversee error-proofing processes and manage torque audits for production accuracy.
+ Validate compliance with windshield primer application, sealer expiration monitoring, material traceability, and any other requirements.
+ Ensure proper VIN stamping for and traceability for body, engine, and transmission components.
+ Perform security audits on VIN Plates and certification labels to prevent discrepancies.
+ Supervise required fluid testing and ensure adherence to regulatory requirements.
+ Work closely with engineering and production teams to resolve compliance-related concerns.
New Model Launch & Change Management:
+ Ensure FMVSS/CMVSS inspection items are recorded in QLS.
+ Participate in new model launch meetings and monitor regulatory validation.
+ Help update NAVIS to reflect compliance requirements.
+ Verify emission certification documents.
EV Specific Management:
+ Ensure compliance with electric vehicle (EV) regulations, including battery safety, charging requirements, and any other initiatives.
+ Monitor evolving government policies and recommend necessary adjustments.
+ Oversee EV-specific regulatory audits and ensure compliance with international standards.
Personnel & Training:
+ Train new Supervisors/Managers on FMVSS requirements.
+ Develop and coordinate backup training for GRC hourly staff.
You'll Have.
+ Bachelor's degree in Engineering, Quality Assurance, or a related field, or equivalent experience.
+ 3+ years of experience in manufacturing quality, vehicle regulations, or audit processes.
+ Strong knowledge of government vehicle regulations, emission standards, and certification requirements.
+ Ability to lead cross-functional teams in regulatory compliance initiatives.
Even Better, You'll Have.
+ Experience with QLS, MCIR, and GSPAS audits.
+ Proficiency in data analysis tools for compliance tracking and reporting.
+ Ability to analyze data, generate reports, and implement corrective action plans.
+ Excellent communication skills for coordinating audits, managing compliance records, and working with regulatory agencies.
+ Highly organized, detail-oriented, and proficient in documentation management.
+ Motivated high achiever with a proactive approach to compliance concerns.
+ Willing to take ownership and responsibility for regulatory processes and audits.
+ Big-picture thinker who drives long-term goals and continuous improvement.
You may not check every box, or your experience may look a little different from what we've outlined, but if you think you can bring value to Ford Motor Company, we encourage you to apply!
As an established global company, we offer the benefit of choice. You can choose what your Ford future will look like: will your story span the globe, or keep you close to home? Will your career be a deep dive into what you love, or a series of new teams and new skills? Will you be a leader, a changemaker, a technical expert, a culture builder.or all of the above? No matter what you choose, we offer a work life that works for you, including:
- Immediate medical, dental, vision and prescription drug coverage
- Flexible family care days, paid parental leave, new parent ramp-up programs, subsidized back-up child care and more
- Family building benefits including adoption and surrogacy expense reimbursement, fertility treatments, and more
- Vehicle discount program for employees and family members and management leases
- Tuition assistance
- Established and active employee resource groups
- Paid time off for individual and team community service
- A generous schedule of paid holidays, including the week between Christmas and New Year's Day
- Paid time off and the option to purchase additional vacation time.
This position is a leadership level 6.
For more information on salary and benefits, click here: sponsorship is available for this position.
Candidates for positions with Ford Motor Company must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status. In the United States, if you need a reasonable accommodation for the online application process due to a disability, please call 1- .
#LI-Onsite #LI-OG1
**Requisition ID** : 47481
Regulatory Affairs
Posted 2 days ago
Job Viewed
Job Description
Join to apply for the Regulatory Affairs role at Planet Pharma 2 days ago Be among the first 25 applicants Join to apply for the Regulatory Affairs role at Planet Pharma Get AI-powered advice on this job and more exclusive features. Job Duties And Qualifications Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision. Description Job Description Job Duties And Qualifications Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision. Essential Functions Acts as a Regulatory Team Leader on more complex projects, which may include technical writing; Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments; Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate; May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development; May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person; May act as reviewer for regulatory standard operating procedures, as assigned and appropriate; May prepare and deliver regulatory training to IQVIA small groups or individuals; Performs other tasks or assignments, as delegated by Regulatory management; Qualifications Bachelor's Degree Degree in Lifescience or related discipline Req Or Master's Degree Degree in Lifescience or related discipline Req At least 3-4 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Possesses a specific regulatory or technical expertise; Good, solid interpersonal communication (oral and written) and organisation skills; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable; Demonstrates self-motivation and enthusiasm; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Pay Rate Range: $30-38/hr depending on experience The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Legal Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Sign in to set job alerts for “Regulatory Affairs Specialist” roles. Regulatory & Study Start Up Specialist II Accreditation, Regulatory, and Licensing Specialist V, Clinical (KFHP/H) Accreditation, Regulatory, and Licensing Specialist V, Clinical (KFHP/H) Quality & Safety Oversight Specialist V, Clinical Quality Oversight (KFHP/H) Director, Accreditation, Regulatory and Clinical Quality Assurance Specialist-Core Laboratory Suitland, MD $16,499.60- 145,624.50 2 weeks ago Quality Assurance Complaints Handling Specialist Corporate Attorney - Regulatory / Maryland Quality Assurance Specialist -Laboratory (Surgical Pathology Lab) Director, Accreditation, Regulatory and Clinical We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Regulatory Affairs
Posted 3 days ago
Job Viewed
Job Description
Description:
Job Duties and Qualifications
Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.
Essential Functions
• Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
• Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
• Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
• Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
• May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;
• May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;
• May prepare and deliver regulatory training to IQVIA small groups or individuals;
• Performs other tasks or assignments, as delegated by Regulatory management;
Qualifications
• Bachelor's Degree Degree in Lifescience or related discipline Req Or
• Master's Degree Degree in Lifescience or related discipline Req
• At least 3-4 years relevant experience
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Possesses a specific regulatory or technical expertise;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
• Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
• Ability to adapt quickly to a rapidly changing environment;
Pay Rate Range: $30-38/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Regulatory Affairs
Posted 7 days ago
Job Viewed
Job Description
We are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are passionate about regulatory affairs and looking for an opportunity to grow within a dynamic company, we encourage you to apply.
Responsibilities:
- Prepare, review, and submit regulatory documents to ensure compliance with FDA and other regulatory authorities.
- Maintain up-to-date knowledge of regulations, guidelines, and standards relevant to the pharmaceutical industry.
- Assist in the preparation of regulatory submissions including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and amendments.
- Coordinate with cross-functional teams to gather necessary information for regulatory submissions.
- Ensure timely and accurate communication with regulatory authorities.
- Monitor and track the progress of submissions and respond to any inquiries from regulatory bodies.
- Assist in the development and implementation of regulatory strategies to support product approvals and lifecycle management.
- Maintain accurate and organized regulatory files and records.
- Bachelor's degree in a related field such as biology, chemistry, or pharmaceutical sciences.
- Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred.
- Strong understanding of FDA regulations and guidelines.
- Excellent organizational and time management skills.
- Strong attention to detail and ability to handle multiple projects simultaneously.
- Effective communication skills, both written and verbal.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and as part of a team.
Regulatory Affairs Coordinator
Posted today
Job Viewed
Job Description
Join to apply for the Regulatory Affairs Coordinator role at Counter 16 hours ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Coordinator role at Counter Description About Us: We are a startup revolutionizing beauty with a purpose; create the industry standard of “clean”. Our premium skincare, makeup, and body care formulations combine uncompromising safety, efficacy and environmental responsibility. And our vision transcends products. We are committed to inspiring confident women (and others) to recognize their collective power to create meaningful change. Our innovative community-commerce ecosystem connects customers, beauty enthusiasts, and loyalists, allowing each person to align with our brand in ways that authentically reflect their values and aspirations. From our formulas to our advocacy efforts to our community connection, we lead clean. In This Role You Will Assist with collecting thorough factual data & information to support the organization. Coordinate with various cross-functional teams and external partners to gather necessary and required information. Perform ingredient assessment based on current domestic and international regulations and standards. Review product promotional materials and labeling for compliance with applicable regulations. Assist in building and maintaining Regulatory Product Information File (PIF)/Product Dossier. Maintain accurate and up-to-date regulatory files and databases. Manage and track project timelines, ensuring that all regulatory deadlines are met. Track and report on the progress of all departmental projects in collaboration with various departments (Product Development, Safety, Quality, Packaging, Marketing, etc.). Provide support to internal stakeholders. Perform raw material and formula database data entry and validation. Stay up to date with relevant regulations and guidelines and provide guidance to the team as needed. Provide regulatory audit support as needed. Help drive process improvement for Regulatory Affairs (RA) department in support of continuous RA process improvement. Assist in communicating with Regulatory agencies and organizations. Perform other appropriate duties or tasks, as assigned by Supervisor Experience 2+ years of experience working in a regulatory department or directly related experience. With 1-2 years of scientific or technical discipline to perform data collection, extraction and analysis. Education Bachelor’s degree in Life Sciences, Law, Business Administration, or a related field (e.g., Chemistry, Biochemistry, Biology, or related science) Skills Must be proficient in Microsoft office, including Excel, PowerPoint and SharePoint. Ability to work to deadlines, set priorities and manage multiple projects simultaneously without compromising quality. Should be able to take notes in a meeting setting and be able to work in a fast-paced environment. Must take directions well and pay attention to detail with a high degree of accuracy. Strong interpersonal skills for collaboration with various departments within the company. Excellent communication, social, and interpersonal skills with the ability to collaborate cross-functionally Salary Description $75,000 Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Legal Industries Retail Referrals increase your chances of interviewing at Counter by 2x Get notified about new Regulatory Affairs Coordinator jobs in Santa Monica, CA . Santa Monica, CA $5,000.00- 75,000.00 2 weeks ago Los Angeles Metropolitan Area 75,000.00- 90,000.00 4 weeks ago Associate/Sr. Regulatory Affairs Associate Pasadena, CA 90,000.00- 120,000.00 2 weeks ago Los Angeles, CA 100,000.00- 150,000.00 3 hours ago Manager, Regulatory Affairs (MLR Coordinator) Pasadena, CA 150,000.00- 175,000.00 5 hours ago Burbank, CA 95,000.00- 135,000.00 2 hours ago Los Angeles, CA 112,000.00- 224,000.00 2 weeks ago Food Safety and Regulatory Affairs Manager San Fernando, CA 15,900.00- 224,000.00 3 weeks ago Los Angeles, CA 112,000.00- 224,000.00 2 weeks ago Vice President, Legal Affairs (Litigation, Regulatory & Public Policy) Bilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA Compliance We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Regulatory Affairs Associate
Posted today
Job Viewed
Job Description
Join to apply for the Regulatory Affairs Associate role at Riverpoint Medical Join to apply for the Regulatory Affairs Associate role at Riverpoint Medical Direct message the job poster from Riverpoint Medical Riverpoint Medical in Northeast Portland is hiring for Regulatory Affairs Associate II . We are hiring for a fully onsite position. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. As a full time, Regulatory Affairs Associate II you will : Support, prepare, and file regulatory submissions for approval, FDA 510(k), EU MDR/CE, and other international markets. Maintain Establishment Registrations, Device Listings and State Licenses both Domestic and International. Prepare and file regulatory notices and notifications for post market surveillance and vigilance. Collaborate with customers to create and maintain technical documentation for regulatory submissions. Generate annual medical device management review reports. Ensure the appropriateness of regulatory standards referenced within Quality System, maintain updated standard library and conduct GAP/risk analysis to determine impact of standard changes/revisions to comply with the state of the art . Review and approve Clinical Evaluation, Post-market Surveillance, and Post Market Clinical Follow-up reports. Review and approve domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conduct regulatory assessments for changes to marketed products. Review quality documents (operational procedures, work instructions, validations, etc.) including but not limited to protocols, for appropriate scientific rationale and for adherence to regulatory requirements/guidance, development strategy. Qualifications for this great opportunity include: Minimum 3-10 years knowledge and experience in Regulatory Affairs in the manufacture and distribution of sterile, disposable medical devices Certified ISO13485 auditor or equivalent job training Ability to create technical dossiers for customer regulatory submissions, experience with 510(k), MDR, Canada, Australia, or Brazil regulatory submissions. Experience with FDA QSR (21 CFR 820), MDR, and MDSAP requirements. Ability to interpret regulations, guidance and correctly apply them as appropriate in product development. Experience with Pre-Market and Post-Market regulatory support, including ISO10993, ISO14971, EN62366, ISO20417, ISO15223, Post Market Clinical Follow-up, Post Market Surveillance, Periodic Safety Update Reports (PSUR), Summary of Safety and Clinical Performance (SSCP), and Clinical Evaluations. Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval. Ability to review detailed scientific information and assess whether technical justifications are presented clearly and conclusions are adequately supported by data. Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks. Customer centric attitude, and experience with customer service is preferred. We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus! Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Seniority level Seniority level Associate Employment type Employment type Full-time Job function Job function Manufacturing Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Riverpoint Medical by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Disability insurance Get notified when a new job is posted. Sign in to set job alerts for “Regulatory Affairs Associate” roles. Portland, Oregon Metropolitan Area $69,000.00-$2,000.00 10 hours ago Regulatory Affairs Specialist (Food Manufacturing Experience) Manager/Senior Manager-Regulatory Affairs-West Portland, OR 125,000.00- 165,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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