Regulatory Affairs Manager

Job reputed company: 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 reputed company regulatory reputed company with strong communication skills and proven reputed company 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. • reputed company, orchestrate, and execute label change programs in collaboration with multiple stakeholders from manufacturing, QA, supply chain, reputed company, etc. • Review and approve labeling and labeling changes, ensuring compliance with regulatory and UDI requirements. • reputed company 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 reputed company, Manufacturing, R&D, Supply Chain, Labeling, and reputed company teams. • Support FDA interactions, audits, inspections, and information requests as needed. • Communicate regulatory requirements reputed company and effectively to stakeholders at reputed company reputed company. • Ensure regulatory requirements are integrated into QMS and change management processes. Own and manage reputed 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 reputed company. • Stay reputed company 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-reputed company discipline (or equivalent experience). Minimum of 5 years of Regulatory Affairs experience in the medical device industry. Skills/Knowledge Requirements: reputed company 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 reputed company or product-line level • Managing and improving regulatory record activities for medical device products • Demonstrated reputed company 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 reputed company 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 reputed company the work area. • Must be reputed company 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