Regulatory Affairs Specialist Ii (post Market Surveillance) - Middletown, Va
PPD (Thermo Fisher) UK
Middletown, VA, United States
Regulatory submissions management
Product lifecycle management
Quality management systems expertise
Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II (Post Market Surveillance), where you'll ensure product compliance and market access for our innovative diagnostic solutions
Job Summary
Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II (Post Market Surveillance), where you'll ensure product compliance and market access for our innovative diagnostic solutions.
You'll work with cross-functional teams to manage regulatory submissions, maintain product registrations, and support quality management systems across global markets.
This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.
Matching Summary
Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II (Post Market Surveillance), where you'll ensure product compliance and market access for our innovative diagnostic solutions.
Skills & Requirements
Must-have
Regulatory submissions management
Product lifecycle management
Quality management systems expertise
Post-market surveillance experience
Cross-functional team collaboration
Technical documentation review
Regulatory information management systems
Nice-to-have
Project management skills
Strong analytical capabilities
Excellent communication skills
Detail-oriented documentation skills
Ability to work in matrix organizations
Fluency in additional languages
Key Requirements
Bachelor's Degree plus 2+ years experience or Advanced Degree
Knowledge of FDA, EU IVDR/MDR, and regional regulations
Regulatory affairs certifications beneficial
Experience with ISO 13485, GMP, MDSAP
Legal authorization to work in the US without sponsorship
Ability to pass background check and drug screening
Work Rights
Must be legally authorized to work in the United States without sponsorship