57 Regulatory Affairs jobs in Addison
Regulatory Affairs Specialist 3 (Addison, TX)
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The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance. Uses technical knowledge to drive new product submissions, listings, and registration of medical devices. Trains and mentors lower-level specialists in regulatory activities.
Responsibilities
- Ensures all processes for the essential functions are documented in procedures.
- Performs internal departmental audits and supports audits by third parties e.g., BSI, FDA and others, as required.
- Initiates and maintains required establishment listings e.g., FDA and EU, including renewal or changes.
- Develops company regulatory strategies and prioritization. Determines the best strategy to register new products in specific global markets.
- Determines appropriate product testing to support registration activities.
- Ensures content accuracy and regulatory compliance for submission to regulatory agencies e.g., 510(k), PMA, MDR Technical Files/Design Dossiers, global registration applications, etc.
- Provides feedback / approval of compliant labeling e.g., IFUs, marketing materials, package labels, etc.
- Manages and leads responses to Regulatory Agency for submission deficiencies.
- Maintains accurate international product registration, including renewal or changes, and certificates for foreign governments.
- Provides direction/guidance as needed to other Regulatory Specialists.
- 5+ years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)
- Evidence of applied knowledge of applicable FDA, ISO, MDR requirements, consensus standards and guidance documents.
- Ability to work under limited supervision with FDA, Notified Body, EU Authorized Representative, and other global regulatory agencies.
- Able to manage multiple projects simultaneously.
- Proven track record of strong teamwork, creatively strategic thinking.
- Ability to work well with others, support regulatory activities and mentor/train others.
- Excellent written and verbal communication skills.
- Master of Science in Regulatory Affairs preferred.
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Regulatory Affairs Associate
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Join to apply for the Regulatory Affairs Associate role at Katalyst CRO
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Join to apply for the Regulatory Affairs Associate role at Katalyst CRO
- Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
- Provides regulatory support for diagnostic product development and commercial diagnostic products.
- Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
- Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
- Researches and communicates scientific and regulatory information to write submission documents.
- Compiles and publishes all material required for submissions, license renewals, and annual registrations.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
- Develops internal procedures and tools.
- Conducts informational or training sessions for stakeholders.
- Organizes and maintains hard copy and electronic department files.
- Demonstrates commitment to the development, implementation, and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
- Provides regulatory support for diagnostic product development and commercial diagnostic products.
- Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
- Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
- Researches and communicates scientific and regulatory information to write submission documents.
- Compiles and publishes all material required for submissions, license renewals, and annual registrations.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
- Develops internal procedures and tools.
- Conducts informational or training sessions for stakeholders.
- Organizes and maintains hard copy and electronic department files.
- Demonstrates commitment to the development, implementation, and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Bachelor's degree in biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
- 4+ years' experience in Regulatory Affairs role.
- Strong knowledge of IVDR and EU regulatory requirements is required.
- Good knowledge of EU and international regulations.
- Demonstrated written and verbal communication skills.
- Strong time management skills, with the ability to work on multiple projects simultaneously.
- Ability to work independently as well as within a team.
- Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio.
- Seniority level Associate
- Employment type Contract
- Job function Legal
- Industries Pharmaceutical Manufacturing
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#J-18808-LjbffrRegulatory Affairs Associate
Posted today
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Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
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#J-18808-LjbffrRegulatory Affairs Manager
Posted 3 days ago
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Direct message the job poster from White & Clayton Recruitment International Headhunter in Food Science | Food Safety | NPD | R&D | Production | Food & Beverage Manufacturing Role: Regulatory Affairs Manager Location: Chicago Position Overview: The Regulatory Manager will be joining a private equity business with iconic brands, strong retail presence, and outstanding manufacturing capabilities. The Regulatory Manager is responsible for ensuring that all company food products comply with applicable regulations, standards, and guidelines issued by federal and state regulatory bodies (e.g., FDA, USDA) as well as applicable certifications. This role involves close collaboration with cross-functional teams such as R&D, Quality Assurance, and Marketing to ensure product compliance from development through commercialization. Responsibilities: • Develop and implement regulatory strategies to ensure compliance with domestic and international food laws. • Perform annual performance appraisals for all direct reports and develop key personnel through coaching, training, and organizational development • Provide technical input throughout all phases of New Product Development (concept through commercialization). • Review and approve product labels, ingredients, nutritional claims, and marketing materials for regulatory accuracy. • Perform data entry, verification and validation of specifications in company PLM system and nutrition software. • Monitor regulatory changes and trends affecting the food industry and communicate impacts to internal stakeholders. • Establish, maintain, and improve upon programs and policies designed to ensure compliance with all relevant third party, customer, state, federal, and global regulatory requirements. • Liaise with regulatory agencies and respond to inquiries, audits, and inspections. • Oversee the preparation and submission of regulatory documentation. • Maintain up-to-date knowledge of FDA, USDA, Codex Alimentarius, and other global food regulatory requirements. • Manage regulatory aspects of product innovation and reformulation. • Train and advise internal teams on regulatory requirements and best practices. • Lead regulatory risk assessments and provide strategic guidance during product development stages. • Drive continual regulatory improvement as measured by key performance indicators and company metrics. • Cross functional collaboration with Quality, R&D, Marketing, Sales, Supply Chain, Finance, and Operations. • Other duties and projects as assigned. • Will need to travel as requested, less than 20%. Qualifications: • Bachelor’s degree in food science, nutrition, regulatory affairs, or a related field. • 5+ years of regulatory affairs experience in the food and beverage industry • In-depth knowledge of food labeling laws, food safety regulations, and ingredient compliance. Personal Characteristics: • Ability to lead, coach, and develop salaried personnel including performing annual performance appraisals for all direct reports and key personnel • Excellent project management and organizational skills • Strong attention to detail, and capacity to multitask efficiently • Excellent communication and interpersonal skills. • Proficiency in regulatory databases, PLM systems and Microsoft Office Suite. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance and Manufacturing Industries Food and Beverage Manufacturing, Food and Beverage Services, and Wholesale Food and Beverage Referrals increase your chances of interviewing at White & Clayton Recruitment by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Paid maternity leave Paid paternity leave Get notified when a new job is posted. Sign in to set job alerts for “Regulatory Affairs Manager” roles. Evanston, IL $100,000.00-$,000,000.00 2 weeks ago Evanston, IL 80,000.00- 100,000.00 1 week ago Manager, Global Regulatory Affairs - Advertising & Promotion Chicago, IL 130,000.00- 150,000.00 2 weeks ago Manager, Regulatory Affairs - Product Development and Post Approval Mgr Regulatory Affairs-Front Line Care (FLC) Manager- Regulatory Compliance (Alternative Assets) Nursing Quality & Regulatory Compliance Manager Sr. Manager, Regulatory Reporting - Capital Markets Chicago, IL 125,000.00- 160,000.00 3 days ago Manager/Sr. Manager, NERC Regulatory Services Chicago, IL 125,000.00- 160,000.00 5 days ago Lending Compliance Auditor/Analyst (Part-Time) Strategic Remediation Validation Specialist - Financial Risk Audit Manager, Regulatory Compliance, Conduct and Legal Audit Senior Product Manager (Compliance & Regulatory Reporting) Chicago, IL 134,400.00- 168,000.00 1 week ago Financial Risk - Regulatory Reporting - Manager Chicago, IL 100,000.00- 232,000.00 2 weeks ago AI & Data Manager - Life Sciences R&D Pharmaceutical Regulatory Regulatory Reporting Accounting Senior Manager Technology - Strategic Remediation Validation Testing Director Financial Risk - Regulatory Reporting, Senior Manager REGULATORY AFFAIRS DOCUMENTATION SPECIALIST I We’re unlocking community knowledge in a new way. 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Regulatory Affairs Manager
Posted 3 days ago
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Regulatory Affairs Manager Remote Regular MERIEUX NUTRISCIENCES As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years. If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us! YOUR DAY TO DAY LIFE We are looking for a Regulatory Affairs Manager in USA. Your mission will be to: The Regulatory Affairs Manager is responsible for providing regulatory compliance services to Merieux NutriSciences' customers in the food, supplement, pet food, and beverage industries, as well as other applicable regulated segments as the business needs grow. The primary focus is on label development/review and nutrition services. This person must be proficient interpreting and ensuring regulatory compliance in accordance with various regulatory requirements for the North American markets. The Regulatory Affairs Manager is also responsible for providing quality checks, continuous improvement activities, management of projects and team support. Main activities: Manages the review of product label projects and/or technical specifications to evaluate label copy, to ensure product compliance with all applicable labeling regulations. Develop or create mandatory labeling materials, including building the ingredient list based on formulation provided, and nutrition facts panels using database, nutrition testing and/or analytical calculations. Provide consultation services on labeling compliance customer inquiries or projects. This includes providing technical feedback by reviewing documentation to substantiate labeling accuracy and claims. Provide assessment on label claims; include defined nutrient/ health claims, factual claims, marketing callout, and romance copy. Maintain up-to-date knowledge of current labeling regulations, regulatory activity and trends. Attend webinars and conferences as necessary to stay up-to-date. Complete industry training sessions as needed to stay current in regulatory knowledge. Engage directly with sales, customers and the regulatory management by participating in key customer or prospect meetings, calls and management of projects. Actively participate and support cross-functional departments on label compliance inquiries. Support and assist in achieving departmental and organizational objectives Perform quality check on projects completed by other team members. Work on company cross-functional regulatory projects as needed Assist with marketing strategies for the department, such as blog writing, educational course assistance, webinar creation, etc. During peak times, support and assist team members with their day-to-day activities to meet customer deadlines Assist in the management of other related duties as assigned such as procedure creation, report design, label audits, or team training May assist Information Services in regulatory research support if needed YOUR PROFILE Profile: Bachelor's degree in Food Science, Nutrition or related science fields, Registered Dietician is a plus Minimum of 5 years of related work experience (Regulatory Compliance or Affairs, Food Labeling or related) Required skills: Strong demonstrated knowledge in food labeling regulations and policies for the US (FDA, USDA, CBP, FTC, TTB) and/ or Canada (Health Canada, CFIA). Knowledge on AAFCO, Mexico and DSHEA regulations a plus Good knowledge of food product development and manufacturing processes is a plus Good understanding of food safety Demonstrate strong ability to explain and interpret complex regulations Demonstrated ability to identify labeling non-compliant issues Demonstrated ability in multi-tasking Strong communication skills, both written and verbal Strong interpersonal skills, comfortable working in a team setting Intermediate mathematical skills Strong system acumen and computer skills Proficient in Microsoft Office and Google applications Takes initiative, self motivated, comfortable multitasking Bilingual in French Canadian or Spanish a plus Management This position falls under the Regulatory Affairs business unit which is part of Technical Services/ Expert Services. Work Environment : The position primarily works in an office/home office environment. Physical dexterity is necessary to effectively manipulate a keyboard. The incumbent can expect extended time spent in a sitting position. Some travel may be required. Compensation Range: $93,000 - $116,000 Annual Salary Potential bonus: Up to 5% based on performance. Full Time Eligible Benefits Overview: Comprehensive medical, dental, and vision insurance plans. Generous paid time off (PTO) package to support work-life balance following state and local ordinances. Optional 401(k) plan with employer matching contributions. The information above provides a general overview and may vary based on specific job responsibilities, location, or other factors. Details will be clarified during the hiring process. #LI-KC #LI-remote WHY JOIN US? Because you would contribute to an inspiring Public Health purpose, supported by long-term and visionary shareholders. Because you would have an impact on our strategic pillars that build on 50 years of experience and expertise. Because you would be part of a community of an enthusiastic and skilled group of people who love co-building together and serving a purpose bigger than them. Because you would be welcome as you are , in a diverse and open-minded environment that is rich in our singularities and differences. Because you would grow in an international group of more than 8200 fantastic team members , with plenty of opportunities to learn and share. Ready for the journey? To apply please click on 'Apply now' button #J-18808-Ljbffr
Regulatory Affairs Manager
Posted 4 days ago
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Join to apply for the Regulatory Affairs Manager role at Katalyst CRO Continue with Google Continue with Google 1 week ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Manager role at Katalyst CRO Get AI-powered advice on this job and more exclusive features. Sign in to access AI-powered advices Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes. This person is instrumental in the design, development, and maintenance of global regulatory processes and business solutions. This is a meaningful individual contributor who will partner with key business, functional and business partners to ensure commercial objectives are achieved. Accountable for all operational aspects including owning, creating and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes that support therapeutic and combination products. Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled process and systems workflows; lead reviews and manage the documents through approvals and governance by cross-functional executive and subject matter authority leadership. Make decisions regarding patient safety signals, indications, risk and other sophisticated change or regulated content creation/modification triggers. Support global implementation of CCDS/CCSI/RSI into country-specific labelling by developing and approving implementation of complex global and local labelling and other regulated solutions in accordance with the end-to-end regulated content, labelling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals. Participate in the execution of regulatory labelling and content strategies for new products and ongoing compliance for products already on the market, including monitoring, evaluating, and internally communicating new and existing applicable regulatory requirements. Lead or support global technology, process, and solution initiatives to standardize, and enable standard process in labelling and content management, including requirements, use cases and translations. Deliver responses, solutions, and find opportunities to improve based upon quality initiatives, including audits and risk mitigation. Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions. Responsibilities The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes. This person is instrumental in the design, development, and maintenance of global regulatory processes and business solutions. This is a meaningful individual contributor who will partner with key business, functional and business partners to ensure commercial objectives are achieved. Accountable for all operational aspects including owning, creating and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes that support therapeutic and combination products. Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled process and systems workflows; lead reviews and manage the documents through approvals and governance by cross-functional executive and subject matter authority leadership. Make decisions regarding patient safety signals, indications, risk and other sophisticated change or regulated content creation/modification triggers. Support global implementation of CCDS/CCSI/RSI into country-specific labelling by developing and approving implementation of complex global and local labelling and other regulated solutions in accordance with the end-to-end regulated content, labelling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals. Participate in the execution of regulatory labelling and content strategies for new products and ongoing compliance for products already on the market, including monitoring, evaluating, and internally communicating new and existing applicable regulatory requirements. Lead or support global technology, process, and solution initiatives to standardize, and enable standard process in labelling and content management, including requirements, use cases and translations. Deliver responses, solutions, and find opportunities to improve based upon quality initiatives, including audits and risk mitigation. Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions. Requirements: Bachelor's degree in pharmacy, biochemistry or similar science related field preferred. Minimum 5 years of pharmaceutical regulatory or regulated content management (e.g., labeling, or Company Core Data Sheets) experience. Ability to run sophisticated projects and timelines in a matrix team environment. Strong project management and organizational skills. Ability to independently identify compliance risks and raise when necessary. Seniority level Seniority level Associate Employment type Employment type Contract Job function Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Manager jobs in Chicago, IL . Chicago, IL $100,000 - $20,000 2 weeks ago Sr Regulatory Affairs Specialist (Remote) - Shockwave Evanston, IL 100,000 - 1,000,000 1 month ago Chicago, IL 76,400.00 - 127,850.00 1 week ago Quality Assurance and Regulatory Affairs Manager Chicago, IL 54,800.00 - 121,100.00 5 days ago Chicago, IL 130,000.00 - 150,000.00 1 month ago Niles, IL 75,000.00 - 90,000.00 2 weeks ago Associate Director, Spectrum & Regulatory Affairs Niles, IL 142,400.00 - 242,100.00 9 hours ago Niles, IL 115,000.00 - 135,000.00 1 month ago Senior Specialist, Regulatory Affairs (Advertising and Promotion), Manager, Regulatory Affairs (Advertising and Promotion) Deerfield, IL 112,000.00 - 155,000.00 1 month ago Chicago, IL 102,400.00 - 204,100.00 4 days ago Manager, Patient Safety & Regulatory-Centralized Fulfillment Program Manager, Regulatory Affairs, Anesthesia & Respiratory Care Chicago, IL 103,200.00 - 154,800.00 4 days ago Senior Specialist, Regulatory Affairs (Advertising and Promotion) Manager- Regulatory Compliance (Alternative Assets) Chicago, IL 70,000.00 - 115,000.00 1 day ago Oakbrook Terrace, IL 102,400 - 204,100 4 days ago Chicago, IL 94,400 - 224,600 3 weeks ago Chicago, IL 95,400 - 192,000 2 weeks ago Manager/Sr. Manager, NERC Regulatory Services Chicago, IL 125,000 - 160,000 2 weeks ago Sr. Manager, Regulatory Reporting - Capital Markets Chicago, IL 125,000 - 160,000 9 hours ago Strategic Remediation Validation - Consultant (Audit and Controls Testing) Financial Risk - Regulatory Reporting - Manager Regulatory Reporting Accounting Senior Manager 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 Manager
Posted 4 days ago
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Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Overall responsibilities To provide regulatory advice and support to the organisation on the content of existing marketing authorisations and for products in development phase. To provide general regulatory advice and support to other departments. Review and approval of promotional and non-promotional material to comply with local regulation, self-regulations and internal policies and procedures. To advice the marketing teams on the promotional activities. Support pharmacovigilance department on safety relevant matters in line with national requirements To support the Head of RA with developing and meeting the longer-term goals for the department Main Accountabilities Obtain marketing authorizations for new pharmaceutical products, working closely with area headquarters. Maintain marketing authorizations as required. Review of promotional and non-promotional materials and activities in accordance with legislation, local procedures and codes of practice. Regulatory advice and support to Brand Team on promotional materials content and activities. Keep updated in current regulations in promotion of medicines and in Spanish Code of Practice for the Pharmaceutical Industry. Liaise and attend meetings with other company functions to provide regulatory advice for new and existing products; participation in affiliate Brand Teams regarding regulatory strategies and proposed label changes, to provide regulatory advice for new and existing products. Provide regulatory support for the Brand Teams commercial divisions in all areas pertaining to product life-cycle management and new product development Liaise with European Regulatory Affairs and Corporate groups on regulatory matters Liaise with national regulatory authorities as required. Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements. Comply with the Company’s policies and procedures to ensure consistency of the current local prescribing information with the CCDS in order to: Ensure alignment within the organization Meet the expectations of regulatory agencies Implement approved label through defined artwork process Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable. Ensure compliance with all relevant statutory requirements and all relevant internal procedures. Represent affiliate regulatory position at defined initiatives or projects from global or area. Reviews and is updated in the industry environment (e.g. regulatory, legal, EFPIA and local codes) and provides regulatory position, perspective and expertise related to advertising and promotion to business partners. Support audits and inspections. Keeps and maintains regulatory operation processes and systems to support regulatory submissions and approvals in the most efficient. Keeps and manages product registration databases to ensure information transmission timely and accurately. Qualifications Degree in Pharmacy, Life Sciences or similar. 10 years of experience in Regulatory Affairs. Strong knowledge of regulations, and special focus on expertise on regulation of promotion and the Farmaindustria Code of Practice. Project Management and Strategic Communication The ability to thrive in a changing environment and to re-prioritise workload to meet business needs. Strong negotiation skills to build consensus. Fluent English language skills Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr
Regulatory Affairs Associate
Posted 4 days ago
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Responsibilities: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
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Regulatory Affairs Specialist
Posted 9 days ago
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Job Description
We are in search of a Regulatory Affairs Specialist to join our growing team. The Regulatory Affairs Specialist is responsible for support in the new and existing product development by contributing to the creation and updating of regulatory strategies in response to evolving requirements.
This role evaluates product lifecycle changes for regulatory impact, ensures compliance with FDA, USEPA, USDA, and other regulatory bodies through thorough assessments and appropriate submissions, and provides general support to the Merchandising team. Initial responsibilities include data entry and electronic filing, while progressively assuming more complex tasks such as supporting labeling, Safety Data Sheet (SDS) development, technical sheet review, and regulatory submissions. This role also supports Research & Development (R&D), internal stakeholders, and external customers,
*** Preference would be the individual resides in the Glenview, IL area, but can be located anywhere within the US for the right individual. This will be a remote position.
Responsibilities Include:
- Develop a foundational understanding of regulatory and legal frameworks, including relevant legislation, policies, and procedures.
- Assist in the development and review of Standard Operating Procedures (SOPs).
- Monitor and communicate changes in the regulatory landscape that may affect BradyPLUS products.
- Maintain up-to-date records of regulatory legislation, relationships, and guidelines.
- Track and report on project timelines and milestones.
- Utilize tracking and document control systems effectively.
- Maintain both paper and electronic document archival systems.
- Prepare routine reports and correspondence with regulatory agencies.
- Review advertising, promotional materials, and collateral associated with new product launches and existing products.
- Coordinate and assist in the preparation of regulatory submission packages.
- Provide support for technical and scientific regulatory activities.
- Prepare, update, and maintain SDSs, labels, and associated materials in compliance with OSHA, FIFRA, CPSC, FDA, DOT, IMDG, IATA, and other regulatory bodies.
- Respond to internal and external customer inquiries and documentation requests.
- Complete jurisdictional or customer-specific safety paperwork upon request.
- Provide guidance regarding storage, handling, and spill cleanup to operations teams.
- Attend industry seminars, conferences, and workshops to stay current with regulatory trends and engage with trade associations and professionals.
- Work with in-house legal team to interpret applicable standards and regulations.
- Additional duties or special projects as assigned.
- Minimum of three years of relevant experience in in Product Compliance, Product Stewardship, or Quality Control, preferably within the distribution industry.
- Bachelor's degree in Business Administration, Supply Chain Management, or a related field.
- Strong analytical and problem-solving skills, with the ability to prioritize and resolve complex issues independently.
- Product compliance related training or certificates with demonstrable knowledge and skills for the role.
- Demonstrate proficiency in Microsoft Office applications.
The pay range for this role is $80,000- $95,000 per year. This range represents what the company reasonably expects to pay an associate for this role based on current market data, internal equity, and other business factors. The actual compensation offered may vary depending on factors such as relevant experience, qualifications, geographic location, and other considerations. In addition to base pay, BradyPLUS offers a comprehensive benefits package to support the health and well-being of our associates and their families. Benefit offerings include medical, dental, vision, life and disability insurance, flexible spending accounts, Employee Assistance Programs (EAP), 401(k) Retirement and more.
BradyPLUS is a leading national distributor of solutions for JanSan, Foodservice and Industrial Packaging. We deliver the right SUPPLIES + SUPPORT to ensure businesses are more successful every day. We offer premium brands, expert advice, and exceptional customer experiences. Our 6,000 associates across 180+ locations have a passion for delivering innovative solutions for the business challenges of today and tomorrow. Together, we serve thousands of customers nationwide in end markets including education, government, healthcare, hospitality, restaurants, building services, food packaging & processing, and grocery. We strive to be the best employer we can. We value people, we embrace change and we reach higher. Join us and see what the BUZZ is about! To learn more visit us at .
BradyPLUS is an Equal Opportunity Employer. This means that all qualified applicants will receive consideration for employment without regard to race, marital status or civil union status, sex, age, color, religion, national origin, veteran status, mental or physical disability, sexual orientation, gender identity and/or any other characteristic protected by law. We also provide reasonable accommodations to applicants and employees with disabilities.
Regulatory Affairs Associate
Posted 12 days ago
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Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
Regulatory Affairs Manager
Posted today
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Job Description
Job Description
Responsible for ensuring FDA regulatory requirements are met for new product introductions and compliance with establishment and product registrations for RWMIC. Manages the post market process under 21 CFR Part 806.
REQUIREMENTS AND RESPONSIBILITIES:
- Oversees and/or executes the creation and submission of 510(k)s, Letters to File (LTF) and associated labeling.
- Ensures timely, appropriate, and complete communication with FDA and other regulatory bodies for premarket and post market activities.
- Leads preparation of external audits. Acts as main company spokesperson during external audits.
- Ensures the preparation and submission of Device Listings and facility registrations.
- Leads Recall and associated field action activities.
- Supports Quality team for regulatory requirements such as FDA Quality System Regulation, 21 CFR 820 & ISO 13485.
- Partners with RW GmbH Regulatory and R&D teams to develop and submit 510k submissions.
- Conducts Regulatory intelligence to gather current and changing requirements. Reports key findings to manager on a regular basis.
- Reviews quality data sources and communicates actionable trends that require further evaluation or investigation.
- Reviews and approves device labeling changes and updates. Manages the Regulatory Affairs team which includes hiring, performance management, training and career development.
- Oversees creation and maintenance of vendor Quality Agreements.
- Conducts training in Quality System Regulation, ISO Standards, and other International Regulations.
- Participates in CAPA activities as needed
- Develops processes and procedures for Regulatory and assures their implementation.
- Promotes and models RWMIC Core Values in all interactions and responsibilities.
ADDITIONAL RESPONSIBILITIES:
- Supports external & internal audits and inspections as required.
- Aware of and complies with the RWMIC Quality Manual and regulations & requirements as they apply to this job type/position.
- Completes all planned Quality & Compliance training within the defined deadlines
- Other duties as assigned by the US Head of Regulatory and Quality Assurance.
QUALIFICATIONS:
- B.S. Degree in an engineering, life science or health-based discipline.
- Minimum of 5 years of experience in Regulatory Affairs within the medical device industry, covering both pre-market and post-market activities, including 3 to 5 years in a managerial position.
- Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams at all levels.
- Strong time management skills, ability to prioritize workloads, and organizational skills.
- Excellent attention to detail and accuracy.
- Experience with filing 510k’s or equivalent experience registering medical devices outside the US.
- Accredited Medical Device certifications: ASQ, RAPS, AAMI, ISO, etc. preferred.
- Intermediate-Advanced PC skills with all MS Office suite products.
- Experience with and understanding of multi-cultural and multi-generational differences and the ability to work within this environment is crucial for successful employment.
- The following physical demands are required:
- Stand/Sit/Walk 8 hours per day
- The following work environment conditions may exist:
- Infectious Disease Exposure
- Chemicals Exposure
- RWMIC offers annual Immunizations for Hep B and Flu Shots to all RWMIC employees. RWMIC employees have the responsibility to themselves and the company to consider receiving these immunizations.
- All RWMIC Employees have the responsibility to themselves and the company to work safely.
We offer competitive wages and a comprehensive benefits package, which includes:
- 401 (k) Retirement Savings Plan and Trust w/Matching Program
- Medical Insurance, Dental and Vision Insurance
- Company Paid Life & Disability Insurance
- Paid Time Off
- Paid Parental Leave
- Telecommuting
- Flexible Schedules
- Tuition Reimbursement
- Wellness Program
- Flexible Spending Accounts
- Unpaid Time Off
At Richard Wolf, we believe in creating a workplace where everyone has the opportunity to thrive. We are committed to providing equal employment opportunities to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, status as a protected veteran, or any other legally protected status. We welcome all qualified candidates to apply for open positions.