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Product Surveillance Analyst

  • Full Time, onsite
  • TekOne IT Services Pvt. Ltd.
  • Saint Paul Church, United States of America
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

  • 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.

Education & Experience

  • 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.