Regulatory Affairs Manager
3 weeks 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.
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Regulatory Affairs Manager
3 weeks ago
Chicago, United States Catalyst Life Sciences Full timeOpportunity 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 ResponsibilitiesLead the US & Canada Regulatory team to...
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Regulatory Affairs Manager
3 weeks ago
Chicago, United States Catalyst Life Sciences Full timeOpportunity 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 ResponsibilitiesLead the US & Canada Regulatory team to...
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Senior Analyst, Regulatory Affairs
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Senior Analyst, Regulatory Affairs
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Chicago, Illinois, United States Adtalem Global Education Full timeJob Description Opportunity at a Glance The Senior Regulatory Affairs Analyst is responsible for interpreting statutes, regulations and administrative rules of various issuing bodies and developing procedures and processes to assure compliance with those rules and monitoring the performance of those procedures and processes. The senior analyst will serve...
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Chicago, Illinois, United States Tempus AI Full timePassionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...
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Regulatory Affairs Associate
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North Chicago, United States Planet Pharma Full timeAccountability / Scope:As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global.Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions...
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