Senior Regulatory Affairs Lead, CDx/FDA Submissions

Foundation Medicine; Boston (MA); Hybrid; USD 101,000 - 127,000; Full time

Benefits offered by this job

Discretionary annual bonus

Benefits package

Job summary

Foundation Medicine in Boston seeks a Senior Specialist, Regulatory Affairs (CDx) to lead regulatory submissions, shape strategy, and guide cross-functional teams through FDA pathways for companion diagnostics.

You will prepare packages, respond to agency inquiries, review validation data, and ensure compliance across regulatory activities, with emphasis on clear scientific writing and collaboration. The role also emphasizes strong communication and meticulous work.

Qualifications

• Bachelor’s Degree and 3+ years of professional work experience; OR Master’s Degree and 1+ year of professional work experience.
• Experience with regulatory submissions for FDA/CDRH and regulatory agencies.
• Ability to interpret scientific data and coordinate multiple submissions

Responsibilities

• Represent the regulatory affairs function on cross-functional project teams.
• Assist in regulatory approval activities for US companion diagnostic devices.
• Prepare, edit and review regulatory submissions (SRDs, IDEs, PMAs, q-submissions, performance study apps).
• Support interactions with regulatory agencies including inspections and submissions.
• Review validation protocols and reports for submission readiness.
• Publish electronic regulatory submissions and maintain regulatory knowledge.

Skills

Regulatory strategy

FDA/CDRH experience

Cross-functional collaboration

Technical writing

Attention to detail

Project management

Education

Bachelor’s Degree

Master’s Degree

Job description

Foundation Medicine in Boston seeks a Senior Specialist, Regulatory Affairs (CDx) to lead regulatory submissions, shape strategy, and guide cross-functional teams through FDA pathways for companion diagnostics.

You will prepare packages, respond to agency inquiries, review validation data, and ensure compliance across regulatory activities, with emphasis on clear scientific writing and collaboration. The role also emphasizes strong communication and meticulous work.