Senior Regulatory Leader, Diagnostics & NDA/PMA

Foundation Medicine; Boston (MA); Hybrid; USD 175,000 - 219,000; Full time

Benefits offered by this job

Bonus potential

Benefits package

Job summary

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

Qualifications

• Bachelor's degree with 8+ years in life sciences, regulatory or related field.
• Master's degree with 6+ years in regulatory affairs or related field or a Doctorate with 3+ years.
• 4+ years of management experience and regulatory affairs experience.

Responsibilities

• Manage premarket submissions for regulatory approval of in vitro companion diagnostic devices in the US.
• Develop and oversee regulatory strategy for complex projects and biopharma partnerships.
• Provide regulatory support for existing products including labeling changes and documentation.
• Author regulatory submission documentation (SRDs, IDEs, PMAs).
• Mentor junior Regulatory Affairs team members and lead cross-functional meetings.

Skills

Regulatory affairs

Leadership

FDA regulatory

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Doctorate degree

Job description

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