Regulatory Affairs
510(k), PMA, and global submissions.
01 —Role overview
Regulatory Affairs specialists prepare and manage submissions to FDA, MDR, and global agencies for new and modified medical devices.
02 —Key responsibilities
What you'll do.
- 01Author and compile 510(k), PMA, De Novo, and EU MDR submissions
- 02Lead pre-submission meetings with FDA
- 03Maintain global device registrations and licenses
- 04Manage labeling and post-market reporting
- 05Advise R&D and Quality on regulatory strategy
03 —Skills & tooling
In demand.
510(k)PMADe NovoEU MDRISO 13485/QMSMDDLabelingFDA
04 —Experience
Typical range
4–12 years
05 —Related roles
More in Medical Devices.
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