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Siemens Healthineers

Remote Senior Regulatory Affairs Specialist

walpole, MA

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Job description

Siemens Healthineers in the United States is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and lifecycle documentation for medical devices and IVDs. You will serve as a regulatory expert, guide design control activities, and collaborate with product teams to ensure QMS alignment and compliance across US and EU markets.

You will prepare technical files, participate in audits, and provide training on country-specific requirements, with a focus on timely execution

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Worksite address

walpole, MA, 02081, US

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