Medical Device Product Safety Analyst

1 week ago

Greater MinneapolisSt Paul Area, United States Planet Pharma Full time

Job ID: 620392

***PLEASE NOTE: THIS ROLE REQUIRES
ONSITE WORK 4 DAYS/WEEK
***

Our client, a leading Medical Device company, is seeking an entry/junior level Product Safety Analyst. This role is ideal for someone who recently completed a Bachelor's Degree and has an interest in the medical device field (there is a robust training. See below for other details:

Responsibilities:

  • Apply policies and procedures to comply with FDA and OUS regulations.
  • Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
  • Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
  • Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
  • Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
  • Maintain awareness of new products, government regulations and requirements.
  • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
  • Other duties as assigned.

Requirements:

  • Bachelor's Degree within some type of Science (Biology, etc) or Biomedical Engineering
  • 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation

Nice to Have

  • Degree in Health Care, Sciences, or Bio-Medical Engineering
  • Medical device industry experience
  • Strong verbal and written communication skills
  • Knowledge of basic anatomy and physiology
  • Strong attention to detail
  • High level of computer proficiency

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