Medical Device Regulatory Expert

3 weeks ago


Minneapolis, Minnesota, United States Inspire Medical Systems I Full time
Medical Device Regulatory Expert Job Summary

We are seeking an experienced Medical Device Regulatory Expert to join our team.

This role offers a competitive salary range of $120,000 - $150,000 per year.

About the Position

The successful candidate will provide regulatory support for implantable neurostimulation therapy in Asia Pacific geographies.

Responsibilities
  • Preparing documentation for submission, including regulatory assessments and design changes.
  • Collaborating with in-country partners to achieve regulatory objectives.
  • Supporting vigilance activities, including field report and complaint management.
  • Interacting with international regulatory partners and foreign regulatory agency reviewers.
  • Reviewing labeling and promotional material for regulatory compliance.
Requirements
  • Bachelor's degree
  • Minimum 1 year experience in medical device industry, preferably in regulatory or quality function.
  • Excellent writing and communication skills.


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