Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist position supporting medical device regulatory submissions and compliance for the orthopaedics portfolio. The role involves preparing regulatory documentation for FDA and international submissions, reviewing labeling and promotional materials, and maintaining compliance with medical device regulations.

Responsibilities

• Prepare regulatory submissions including IDE, 510(k), PMA, Design Dossiers, and Technical Documentation for FDA and regional authorities
• Support global registration activities for markets including Japan, China, Australia, and New Zealand
• Review and approve device labeling and product support information for regulatory compliance and consistency with approvals
• Evaluate product lifecycle management changes for impact on notified bodies, FDA, and global requirements
• Maintain knowledge of applicable FDA regulations, European standards, ISO 13485, and medical device guidance documents

Requirements

• Minimum 2 years regulatory affairs or medical device industry experience
• Knowledge of FDA and EU medical device regulations (MDR, MDD)
• Bachelor's degree required
• Excellent written and oral communication skills
• Ability to manage multiple tasks with strong attention to detail
• Familiarity with electronic submission preparation preferred
• Orthopedic implants knowledge preferred