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Regulatory Affairs Specialist III
Katalyst Healthcares & Life Sciences
📍
Chicago, Illinois, United States
Location
Chicago, Illinois
Posted
May 06, 2026
Commute
Local Area
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Job Description
Responsibilities:
- The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices)
- The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards
- Develop regulatory strategies to achieve market clearance in an effective and efficient manner
- Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable:
- 510(k) and/or De Novo submissions for FDA
- Technical documentation for EU MDR compliance
- International product...