Job Description

Zimmer Biomet seeks a Regulatory Affairs Manager to develop and execute regulatory strategies for medical devices while ensuring FDA and international compliance. The role serves as primary liaison with regulatory authorities and cross-functional teams throughout the product lifecycle.

Responsibilities

• Author and submit U.S. and global regulatory filings including 510(k)s, IDEs, and EU technical documentation
• Maintain and update regulatory SOPs and work instructions aligned with current regulations and guidance
• Monitor evolving regulations and drive implementation of required changes across product design and QMS
• Serve as primary liaison with FDA, notified bodies, and other regulatory authorities for approvals and registrations
• Establish and manage Post-Market Surveillance and Post-Market Clinical Follow-Up activities in compliance with global requirements

Requirements

• Bachelor's degree in relevant discipline
• Minimum 8 years medical device regulatory affairs experience
• International regulatory experience required
• In-depth knowledge of FDA regulations (21 CFR Part 820) and ISO 13485
• Experience with 510(k), CE mark, and international submissions
• Strong project management and cross-functional leadership skills
• Regulatory Affairs Certification (RAC) preferred

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