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Regulatory Affairs Associate

3 months ago

St Paul, United States Redbock - an NES Fircroft company Full time

**CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY**

Associate MDR/Vigilance Specialist (24 month contract // Hybrid in Mounds View, MN):

Mon/Tues on site/in-office, Wed-Fri remote

Top 3 things the manager is looking for:

  1. Medical Device Reporting experience
  2. Previous healthcare experience
  3. Medical device industry experience

Top 3 Tasks in Scope for this role:

  1. Review incoming complaints from the field
  2. Go back out to the field for further information on complaints
  3. File regulatory reports

Position Summary:

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 clients Surgical Devices 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.

Duties:

  • 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

Must Have experience:

  • 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