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Analyst, Product Surveillance in Minneapolis, MN at Volt

Date Posted: 6/10/2019

Job Snapshot

  • Employee Type:
  • Job Type:
  • Duration:
    48 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch

Job Description

Volt has an opening for a Postmarket Surveillance Analyst II for a client in Plymouth MN

Volt's Client is an American healthcare company that has a broad range of branded generic pharmaceuticals, medical devices, diagnostics, and nutrition products.

Postmarket Surveillance Analyst II – (8am to 4:30pm)

  • Knowledge of the use, development, and regulatory environment of medical devices is a plus.
  • Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting is a plus.
  • Knowledge of global regulations for medical device reporting and medical terminology is a plus
  • Strong written and oral communication skills are required
  • Good problem-solving and proficient computer skills are required
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Effectively multitasks, prioritizes and meets timelines
  • Strong organizational and follow-up skills, as well as attention to detail

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.

Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.

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.

This position is Non-Exempt.

Volt is an equal opportunity employer

PLEASE NOTE: Local candidates only please apply and call Debra Brock for immediate information on this role.