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Sr. Regulatory Affairs Specialist

Katalyst Healthcares & Life Sciences • Irvine, CA, US • published 2026-09-29 02:55:16.067735

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 obtaining and/or maintaining regulatory approval/clearance for Client products * Assist in preparation and review of regulatory submission to authorities. * Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action. * Utilize technical regulatory s...

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