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Senior Medical Device Regulatory Strategist

Tactile Medical

Tactile Medical is seeking a Principal Specialist of Regulatory Affairs to govern regulatory compliance across the product lifecycle. You will develop strategies for new and existing products, interact with cross-functional leaders, and drive global filings. You will lead 510(k) submissions, PMAs, IDEs as appropriate, maintain UDI/GUDID data, and shape policies. The role requires a Bachelor’s degree and 7+ years in medical device regulatory affairs. #J-18808-Ljbffr

Vacancy posted 2 days ago
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