- Strategy planning & product classification
- Liaise with regulatory agencies on regulatory matters, organize and manage meetings, respond to regulatory agency questions
- FDA Medical Device Establishment Registration
- FDA 510k Premarket Notifications
- FDA PMA Submissions
- CE Mark certification
- MDL and MDEL registrations & renewals for Health Canada
- Label reviews
- Medical device reporting
- SOP & PnP preparation and review
- Medical writing
