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.