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Sr. Regulatory Affairs Specialist
Katalyst Healthcares & Life Sciences
📍
Irvine, California, United States
Location
Irvine, California
Posted
May 16, 2026
Commute
Local Area
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Job Description
Responsibilities:
- Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
- Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
- Assist in SOP development and review in support of "next-gen " product offerings.
- Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
- Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval.
- Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for...