Regulatory Affairs Senior Specialist

Zimmer Biomet seeks a Senior Specialist in Regulatory Affairs to manage submissions, documentation, and compliance strategy for medical devices. The role involves coordinating regulatory processes, authoring submissions, evaluating product changes, and providing guidance to development teams across US and international markets.

Responsibilities

• Organize and track regulatory submissions, documentation, storage, and retrieval
• Author and publish electronic regulatory submissions and package inserts
• Respond to government and distributor requests for marketing approval documentation
• Research and communicate appropriate regulatory pathways for new or modified products
• Review labeling, promotions, and product changes for regulatory compliance

Requirements

• 5 years of regulatory affairs or related experience
• 2 years in orthopaedic or medical device industry
• 3 years working with FDA and EU regulations including labeling
• Advanced anatomic knowledge
• Knowledge of medical device, biologic, and combination product regulations
• Experience identifying regulatory strategy risks
• Bachelor's degree in Technical Engineering, Mechanical Engineering, or related field

Compensation: $108,701 base per year minimum, depending on education and experience