Teams at Foundation Medicine

Lead regulatory strategy and submissions (IDE, PMA, SRDs) for companion diagnostic in vitro assays using NGS. Manage a 3-5 person team, support product development, review technical and labeling changes, interface with FDA and external partners, and ensure software/data validation and regulatory compliance for marketed products.

Serve as primary liaison for key biotech/healthcare accounts to ensure excellent end-to-end customer experience, resolve operational issues, analyze ordering patterns, implement process improvements, coordinate cross-functional solutions, and travel to support assigned territory (up to 60%).

Support, maintain, and improve automated laboratory systems (liquid handlers, robots, microplate readers) for clinical assays. Install and qualify instruments, author SOPs, coordinate vendor service, collect reliability data, train end users, and provide on-call and off-hours support in a regulated clinical laboratory environment.