Upvote
Downvote
Regulatory Affairs Manager
Share Job
- Suggest Revision
$150
- The Regulatory Affairs Manager position is responsible for the preparation of regulatory submissions required to market in vitro diagnostic devices in both domestic and international markets.
- Prepare and manage regulatory submissions (e.g., pre-submissions, IDE, PMA, Technical Files, and other regulatory documentation) for product approvals required by the U.S. FDA and ex-U.S. regulatory bodies.
- Assist in the planning and designing of analytical and clinical validation studies, as well as post-market studies, to support U.S. FDA, CLIA, and ex-U.S. regulatory requirements.
- Work closely with quality assurance to ensure design controls are implemented properly during the product development process.
- Bachelor's Degree Biology, Chemistry, Physics, or other similar scientific field.
Active Job
Updated TodaySimilar Job
Relevance
Active