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West Pharmaceutical Services

Regulatory Affairs Lead - Digital Health & AI Med Devices

exton, PA

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Job description

West Pharmaceutical Services seeks a Manager of Regulatory Affairs Digital Health & Innovation to lead regulatory strategies for software-enabled medical devices (SiMD/SaMD) and other digital health solutions. You will partner with R&D, Quality, and Product Management to plan pathways, ensure cybersecurity compliance, and drive lifecycle submissions.

The role emphasizes shaping AI-enabled tool adoption, regulatory documentation, and cross-functional collaboration across U.S., EU, and global

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Worksite address

exton, PA, 19341, US

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