Sr Specialist/Group Manager, Regulatory Affairs
On-site · Norristown, Pennsylvania, United States
Norristown, Pennsylvania, United StatesOn-siteFull TimeSenior LevelBachelors DegreeUnknown
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Sr Specialist/Group Manager, Regulatory Affairs leads FDA submissions for orthopedic medical devices (510(k), IDE, PMA), partners with Product Development to align regulatory strategy, reviews clinical data to support submissions, maintains PMA records and prepares supplements and annual reports, and trains team while contributing to SOP development and regulatory compliance.
Required Qualifications
- Bachelor’s in health/science-related field; Engineering degree is a plus
- 5+ years’ experience in Regulatory Affairs in the medical device industry
- Knowledge of orthopedic medical devices is highly preferred
- Comfortable with FDA regulatory pathways and submission types (Pre-Sub, 510(k), IDE, PMA)
- Strong documentation, review, and cross-functional communication skills
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