Regulatory Affairs Specialist – Minneapolis, MN

Position Summary

This person will provide regulatory support for a first of its kind, implantable neurostimulation therapy for the treatment of obstructive sleep apnea. They will initially focus on manufacturing change assessments and submissions in the US and Europe, annual reports, labeling and promotional material reviews.  They will also have opportunity to gain a broader range of regulatory experience with design change and new product development submissions in the US and internationally.

 

Main Duties/Responsibilities

  • Conduct regulatory assessments of manufacturing changes, e.g. engineering change orders and supplier change requests
  • Develop annual report submissions, as well as submissions for manufacturing changes in the US and EU, e.g. PMA 30-Day Notices, and design dossier amendments
  • Work with technical experts in product development, quality, and clinical to address questions from regulatory agencies
  • Interact directly with FDA and international regulatory agencies at the reviewer level
  • Review labeling and promotional material for regulatory compliance

 

Qualifications

Education and Experience Requirements:

  • Bachelor’s degree with 2+ years medical device industry experience, preferably in regulatory, quality, and/or engineering.

Desired/Preferred Qualifications:

  • Regulatory compliance experience, e.g. regulatory assessment of design and manufacturing process changes
  • Regulatory submission experience e.g.:
    • FDA
    • EU Notified Body
    • PMDA
  • Education and/or work experience in a technical or scientific field
  • Experience working in the medical device industry

 

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