Global Medical Device Regulatory Lead Associate Director

A leading biotechnology company in the US seeks a Global Regulatory Affairs Device Lead (Associate Director) to manage regulatory strategies for medical devices and combination products. This position requires over 8 years of relevant experience, including substantial regulatory experience with medical devices. The ideal candidate will provide guidance to cross-functional teams, lead health authority interactions, and develop regulatory submission strategies. The role demands strong collaboration skills and is based in Framingham, MA with a hybrid work model (60% on-site).
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