Role: Product Surveillance Analyst
Location: St. Paul, MN or Plymouth, MN
Duration: 11 Months (Contract-to-Hire)
Shift Timings: 6:00 AM - 3:00 PM or 9:00 AM - 6:00 PM
Responsibilities:
- Perform multiple functions within the post-market surveillance department.
- Major duties include:
- Classification, review, and disposition of adverse events and medically related complaints for on-market products.
- Evaluate seriousness, reportability, and potential causality of complaints.
- Complete FDA MDR reports and regulatory reports for other competent authorities.
- Analyze and submit complaints and investigate returned products from the field (includes biohazard products used in surgeries).
Experience & Education:
- 0–2 years of experience.
- Preferred: Post-market surveillance experience in the Medical Device or Pharmaceutical Industry.
- Bachelor’s degree in healthcare or science fields preferred (e.g., biology, chemistry, life sciences).
- Alternatively, a two-year degree with relevant experience in complaint handling investigations, medical device reporting, or product analysis.
- Candidates with a four-year degree without specific medical or scientific experience may be considered if they demonstrate strong suitability for the role.
Skills:
- Strong organizational and prioritization skills.
- Cross-functional communication skills.
- Experience in complaint handling and product performance investigations is a plus.
Lab experience for product investigations is desirable.