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Regulatory Affairs Manager
4 months ago
Opportunity to join a global diagnostics company at their HQ just outside of 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 to prepare the documentation and submissions for 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.
