Associate Director, Regulatory Affairs

Role: Associate Director of Regulatory Affairs supporting FMI's molecular diagnostic products, primarily NGS-based companion diagnostics for cancer. Responsibilities: develop and lead regulatory strategy for FDA premarket submissions (SRDs, IDEs, PMAs), manage approval processes, review engineering changes, labeling, and promotional materials for compliance, and support existing product lifecycle activities. Lead a team of 3-5, collaborate with product development and external partners on genomic biomarker and diagnostic indication development, and interface with regulatory authorities. Qualifications: Bachelor's (8+ years), Master’s (6+ years), or Doctorate (3+ years) in life sciences, regulatory affairs, or related, with a minimum of 4 years management experience and extensive regulatory experience. Preferred skills include FDA regulatory expertise, interpretation of clinical data, and strong communication; familiarity with software validation, GxP, and clinical trial phases is advantageous. High-Value: focus on in vitro diagnostic device approval, NGS technology, cancer biomarker development, regulatory submissions to FDA (including PMA), and cross-functional team leadership. Worksetup: based in Boston, MA, with potential for remote work; salary range $175,350–$219,200, with bonus and benefits.