- May perform multiple functions within the postmarket surveillance department.
- Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality.
- Complete FDA MDR and other outside competent authority regulatory reports.
- Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry. At least one year of experience with MDR and OUS regulatory reporting experience required.
- Knowledge of the use, development, and regulatory environment of medical devices. Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting.
Sthree US is acting as an Employment Business in relation to this vacancy.