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Regulatory Affairs Specialist

Agilent Technologies • Sacramento, CA, US • published 2026-09-28 14:55:08.966207

Description

**Job Description** ------------------- The Regulatory Affairs Specialist will be responsible for ensuring global product compliance and adherence to applicable regulatory requirements. This role supports regulatory submissions for product marketing in international markets and contributes to maintaining compliance across the company’s IVD portfolio. The position supports new product development by providing regulatory input and guidance throughout the product lifecycle from design and development through commercialization to ensure compliance and timely market access. * Responsibilities also include monitoring evolving global regulations, assessing their impact on company operations, and supporting updates to processes and documentation as needed. * Additional activities include maintaining regulatory documentation, assisting with post\-market compliance, and contributing to internal training and continuous improvement initiatives within the Regulatory Affairs function. * Prepare, coordinate, and submit regulatory documentation and product registrations for key global markets, including the U.S. (FDA), EU (IVDR), Canada, LATAM, Asia\-Pacific, Middle East, and MDSAP\-participating ...

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