Senior Regulatory Affairs Manager

  • Posted: 24/04/2024
  • Salary: Competitive
  • Location: Chicago, Illinois, United States
  • Job Type: Permanent/Fixed Term
Opportunity to join a global IVD company at their US HQ in Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements.

Main Responsibilities
  • Lead the US & Canada Regulatory team through the preparation of documentation and submissions for the FDA and Health Canada, as well as the responses to regulatory agencies.
  • Manage the maintenance of device registrations and ongoing compliance activities.
  • Responsible for the ongoing reviewing of regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards.
Experience Required
  • 6 years' Regulatory Affairs experience within Medical Devices or IVDs, understanding FDA requirements for 510(k)s and 21 CFR 820.
  • Prior management or team leadership experience.
  • Experience working directly with regulatory agency representatives.
  • This is a hybrid role that requires at least 3 days a week onsite in Chicago, IL.
Callum Sparkes Director

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