Regulatory Affairs Manager
Job Summary:
The Regulatory Affairs Manager supports U.S. medical device regulatory activities in a hands-on, individual contributor role. The position has primary responsibility for FDA regulatory compliance, change control review, labeling updates, 510(k) submissions, and UDI program ownership across a medical device portfolio.
This role requires a highly collaborative regulatory professional with strong communication skills and proven success working in a fully remote, cross-functional team environment.
Essential Duties and Responsibilities:
• Serve as a regulatory subject matter expert for FDA medical device regulations (21 CFR).
• Prepare, author, and support FDA 510(k) submissions, including documentation updates and responses.
• Develop, orchestrate, and execute label change programs in collaboration with multiple stakeholders from manufacturing, QA, supply chain, commercial, etc.
• Review and approve labeling and labeling changes, ensuring compliance with regulatory and UDI requirements.
• Lead and support regulatory documentation changes, including technical file updates and regulatory assessments.
• Own and improve recordkeeping activities for products, ensuring accurate, compliant regulatory records across the product lifecycle.
• Partner cross-functionally with Quality, Manufacturing, R&D, Supply Chain, Labeling, and Commercial teams.
• Support FDA interactions, audits, inspections, and information requests as needed.
• Communicate regulatory requirements clearly and effectively to stakeholders at all levels.
• Ensure regulatory requirements are integrated into QMS and change management processes.
Own and manage the company’s UDI program, including:
• UDI assignment and maintenance
• Labeling implementation
• Database submissions and updates
• Review and approve manufacturing change controls, including design, process, supplier, and manufacturing changes for regulatory impact.
• Stay current with evolving regulatory requirements impacting U.S. medical devices and UDI.
Education, Certifications and/or Work Experience Requirements:
Bachelor’s degree in a scientific, engineering, or regulatory-related discipline (or equivalent experience).
Minimum of 5 years of Regulatory Affairs experience in the medical device industry.
Skills/Knowledge Requirements:
Direct experience:
• Strong working knowledge of FDA medical device regulations.
• Writing and supporting FDA 510(k) submissions
• Reviewing manufacturing change controls
• Reviewing and approving labeling and labeling changes
• Owning and maintaining a UDI program at the company or product-line level
• Managing and improving regulatory record activities for medical device products
• Demonstrated success working as an individual contributor.
• Proven experience working effectively in a remote environment with cross-functional teams.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple priorities independently.
Physical Requirements:
• Requires the ability to communicate effectively through verbal and written means.
• Occasional travel may be required, including the ability to travel by car or air to attend meetings, audits, inspections, or company events.
• This position is performed in an office or home-office (remote) setting.
• Requires the ability to sit for extended periods of time while working at a computer.
• Requires frequent use of computer equipment, including a keyboard, mouse, and monitor.
• May involve occasional standing, walking, bending, or reaching within the work area.
• Must be able to view and work with electronic documents, spreadsheets, and regulatory systems.
• May require occasional lifting of up to 10 pounds, such as office supplies or files.
Apply tot his job
Apply To this Job
The Regulatory Affairs Manager supports U.S. medical device regulatory activities in a hands-on, individual contributor role. The position has primary responsibility for FDA regulatory compliance, change control review, labeling updates, 510(k) submissions, and UDI program ownership across a medical device portfolio.
This role requires a highly collaborative regulatory professional with strong communication skills and proven success working in a fully remote, cross-functional team environment.
Essential Duties and Responsibilities:
• Serve as a regulatory subject matter expert for FDA medical device regulations (21 CFR).
• Prepare, author, and support FDA 510(k) submissions, including documentation updates and responses.
• Develop, orchestrate, and execute label change programs in collaboration with multiple stakeholders from manufacturing, QA, supply chain, commercial, etc.
• Review and approve labeling and labeling changes, ensuring compliance with regulatory and UDI requirements.
• Lead and support regulatory documentation changes, including technical file updates and regulatory assessments.
• Own and improve recordkeeping activities for products, ensuring accurate, compliant regulatory records across the product lifecycle.
• Partner cross-functionally with Quality, Manufacturing, R&D, Supply Chain, Labeling, and Commercial teams.
• Support FDA interactions, audits, inspections, and information requests as needed.
• Communicate regulatory requirements clearly and effectively to stakeholders at all levels.
• Ensure regulatory requirements are integrated into QMS and change management processes.
Own and manage the company’s UDI program, including:
• UDI assignment and maintenance
• Labeling implementation
• Database submissions and updates
• Review and approve manufacturing change controls, including design, process, supplier, and manufacturing changes for regulatory impact.
• Stay current with evolving regulatory requirements impacting U.S. medical devices and UDI.
Education, Certifications and/or Work Experience Requirements:
Bachelor’s degree in a scientific, engineering, or regulatory-related discipline (or equivalent experience).
Minimum of 5 years of Regulatory Affairs experience in the medical device industry.
Skills/Knowledge Requirements:
Direct experience:
• Strong working knowledge of FDA medical device regulations.
• Writing and supporting FDA 510(k) submissions
• Reviewing manufacturing change controls
• Reviewing and approving labeling and labeling changes
• Owning and maintaining a UDI program at the company or product-line level
• Managing and improving regulatory record activities for medical device products
• Demonstrated success working as an individual contributor.
• Proven experience working effectively in a remote environment with cross-functional teams.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple priorities independently.
Physical Requirements:
• Requires the ability to communicate effectively through verbal and written means.
• Occasional travel may be required, including the ability to travel by car or air to attend meetings, audits, inspections, or company events.
• This position is performed in an office or home-office (remote) setting.
• Requires the ability to sit for extended periods of time while working at a computer.
• Requires frequent use of computer equipment, including a keyboard, mouse, and monitor.
• May involve occasional standing, walking, bending, or reaching within the work area.
• Must be able to view and work with electronic documents, spreadsheets, and regulatory systems.
• May require occasional lifting of up to 10 pounds, such as office supplies or files.
Apply tot his job
Apply To this Job