Regulatory Affairs Specialist Ii (post Market Surveillance) - Middletown, Va
PPD (Thermo Fisher) UK
Middletown, VA, US
Global regulatory requirements knowledge
Quality management systems expertise
Technical documentation preparation
This role ensures product compliance and market access for innovative diagnostic solutions within a global team
Job Summary
This role ensures product compliance and market access for innovative diagnostic solutions within a global team.
The position involves managing regulatory submissions, maintaining product registrations, and supporting quality management systems across international markets.
Joining the Thermo Fisher Scientific team offers opportunities to contribute to a mission of making the world healthier, cleaner, and safer.
Matching Summary
This role ensures product compliance and market access for innovative diagnostic solutions within a global team.
Skills & Requirements
Must-have
Global regulatory requirements knowledge
Quality management systems expertise
Technical documentation preparation
Product lifecycle management experience
Post-market surveillance capabilities
Nice-to-have
Cross-functional team collaboration
Project management skills
Additional language fluency
Regulatory affairs certifications
Matrix organization experience
Key Requirements
Advanced Degree or Bachelor's with 2+ years experience
Life Sciences, Chemistry, Pharmacy, or Engineering degree
Legal authorization to work in US without sponsorship
FDA, EU IVDR/MDR, and regional regulation knowledge
ISO 13485, GMP, MDSAP understanding
Work Rights
Must be legally authorized to work in the United States