Medical Device Regulatory Associate

4 weeks ago

Minneapolis, United States Planet Pharma Full time

In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for company products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.

Neuroscience

The Neuroscience Portfolio group develops life-restoring therapies and healthcare solutions that span the neurological care continuum including integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

A Day in the Life

Responsibilities include the following but not limited to:

  • 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.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelor degree
  • High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc)
  • 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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