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Senior Specialist, Regulatory Affairs

Advanced Bionics • Valencia, CA, US • published 2026-10-24 08:05:11.097556

Description

166087 Valencia, CA – Hybrid (3 days onsite) **Senior Specialist, Regulatory Affairs** Advanced Bionics is seeking a Senior Specialist, Regulatory Affairs to develop and execute regulatory strategies supporting product approvals and registrations across international markets, with a focus on the Asia\-Pacific (APAC) region. This hybrid role requires strong experience with Class III medical devices, PMA submissions, and global regulatory requirements. The Senior Specialist will collaborate with cross\-functional teams throughout the product development lifecycle to ensure regulatory compliance, maintain product registrations, and support timely market approvals. **Responsibilities:** * Develop and execute regulatory strategies to obtain and maintain product approvals and registrations across international markets, including APAC, EU, Canada, LATAM, and MENA. * Prepare and manage regulatory submissions, including PMAs, PMA supplements, 510(k)s, IDE applications, CE marking applications, and international product registrations. * Provide regulatory guidance throughout the new product development lifecycle, including design controls, manufacturing processes, and sustaining engineering ...

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