Post Market Surveillance Specialist
Experience: 3 - 5 years
Skills:
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.
Education:
Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis.
Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
Duties:
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.
• Max BR: $30
• Potential to extend contract
• Managing product experiences determining classification, disposition of adverse events, complaints for post market products, sending FDA medical reports to Regulatory locations (Europe and Hong Kong), etc.
• Flexible working hours (i.e. can start earlier than 9am to be able to end earlier)
• On-site in Minnetonka, MN with potential to work 1 day from home after adequate training (subject to change)
• 3-5 years of experience with complaints handling and MDR/MDV reporting preferred; willing to consider 0-2 years of experience for the right candidate
• 1-year MDR for FDA and OUS (Europe/Hong Kong) experience highly preferred
• 4-year degree in Healthcare or Science or a 2-year degree with more experience required
• MS Suite Experience required
• Ability to work independently and as a team member, able to multitask, attention to detail
• Interview to be held on-site in Minnetonka (depending on logistics/availability) or via Microsoft Teams video call
• Full address of on-site office: 14900 Minnetonka Industrial Road Building 7 Minnetonka, MN 55345 USA