Product Surveillance Analyst
Salary undisclosed
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Role: Product Surveillance Analyst
Location: St. Paul, MN (with potential work at Plymouth, MN location)
Duration: 11 Months (Contract-to-hire)
Shift Timings: 7 AM to 4 PM OR 9 AM to 6 PM
Key Responsibilities
Location: St. Paul, MN (with potential work at Plymouth, MN location)
Duration: 11 Months (Contract-to-hire)
Shift Timings: 7 AM to 4 PM OR 9 AM to 6 PM
Key Responsibilities
- Perform multiple functions within the post-market surveillance department.
- Classify, review, and dispose of adverse events and medically related complaints for on-market products.
- Make decisions on the seriousness, reportability, and potential causality of complaints.
- Complete FDA MDR and other regulatory authority reports.
- Analyze complaints and investigate returned products from the field (some products may have biohazard risks as they are used in surgery).
- Manage the complaint handling process from start to finish, ensuring effective cross-functional communication.
- 1 - 2 years of related experience in post-market surveillance, preferably in the Medical Device or Pharmaceutical industries.
- Lab experience for product investigation is preferred.
- Four-year degree in healthcare or science fields (preferred) OR
- Two-year degree with relevant experience in complaint handling investigations, medical device reporting, or product analysis.
- Candidates without medical/scientific or complaint handling experience may be considered based on other suitable strengths.
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