Regulatory Affairs Sr Specialist

Senior Regulatory Affairs Specialist at a global medical technology company responsible for managing regulatory submissions, developing regulatory strategies for medical devices, and ensuring compliance with FDA and international regulations. The role involves cross-functional collaboration with development teams and government agencies.

Responsibilities

• Assemble, manage, and track regulatory documentation; author and publish electronic submissions
• Prepare and submit marketing approval documentation for foreign governments and distributors
• Research and communicate appropriate regulatory pathways for new or modified products
• Develop regulatory strategy for new products and provide direction to development teams
• Review labeling, package inserts, promotional materials, and product changes for regulatory compliance

Requirements

• Bachelor's degree required; technical, engineering, or life sciences preferred
• Minimum 5-6 years regulatory affairs, engineering, or quality experience
• Advanced degree preferred
• Mastery of medical device, biologic, drug, and combination product regulations
• Strong writing, communication, and interpersonal skills with attention to detail
• Proficient knowledge of orthopaedic industry and marketplace
• Advanced anatomic knowledge and robust product knowledge