The Regulatory Affairs Specialist II

Regulatory Affairs Specialist II will execute regulatory activities supporting marketed orthopaedic devices and new product development for DePuy Synthes. The role encompasses preparing regulatory submissions, managing agency interactions, reviewing product changes, and providing regulatory guidance across multiple jurisdictions and device types.

Responsibilities

• Prepare and submit regulatory documentation to FDA and international health authorities for devices and design changes
• Review engineering modifications to marketed products and assess regulatory submission requirements
• Ensure product labeling and claims comply with premarket clearances and applicable regulations
• Provide regulatory guidance and support to project teams on design controls, promotional materials, and pathways
• Maintain compliance knowledge of FDA QSR, European standards, ISO 13485, and evolving medical device regulations

Requirements

• Sound regulatory judgment and knowledge of FDA and international medical device regulations
• Experience preparing regulatory documentation including 510(k), IDE, PMA, and technical files
• Cross-functional collaboration skills and ability to work with engineering and project teams
• Familiarity with FDA Quality System Regulations, ISO 13485, and European Medical Device Regulation
• Knowledge of orthopaedic or medical device regulatory pathways