Senior Regulatory Leader, Diagnostics & NDA/PMA

Posted 2 days ago

foundation medicineEast Boston (MA)

Regulatory Affairs Managers Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Manager

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About the role

Foundation Medicine is seeking an Associate Director, Regulatory Affairs in Boston to lead regulatory strategy and manage FDA submissions for diagnostic assays. You will guide complex projects, collaborate with product development and biopharma partners, and mentor a small team of regulatory professionals. The role requires significant regulatory affairs experience, strong leadership, and the ability to interface with regulators and cross-functional teams to ensure compliant product development

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