Sr Regulatory Affairs Specialist

Foundation Medicine; Boston (MA); On-site; 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

About the Job:

The Senior Specialist, Regulatory Affairs (CDx) performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to health authorities such as FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document packages for regulatory agencies and ensures compliance with all requirements.

Key Responsibilities:

• Represent the regulatory affairs function on assigned cross-functional project teams.


• Assist in activities associated with regulatory approval of in vitro companion diagnostic medical devices in the US market.


• Write, prepare, edit and review regulatory submissions to expand indications of currently marketed products; documents include, but are not limited to:


• Significant Risk Determination Requests (SRDs);
  
  
  • IDE applications;
  
  
  • Q-Submissions;
  
  
  • Pre-market applications (PMAs, sPMAs); and,
  
  
  • Performance Study Applications
  
  


• Support and eventually manage interactions with regulatory agencies including responses to regulatory inspections and regulatory submissions.


• Support companion diagnostic regulatory strategy (analytical and clinical validation) and regulatory filings.


• Review validation protocols and reports for regulatory submission soundness.


• Publish electronic regulatory submissions.


• Represent FMI before regulatory authorities and biopharmaceutical partners on regulatory and technical matters, as needed.


• Provide support for marketed products, e.g., review engineering changes, labeling, promotional material, and product changes for compliance.


• Support change control activities that require regulatory agency approval per US regulatory requirements.


• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects.


• Draft submission documents with other subject matter experts as needed.


• Review and edit technical documents to be included in submission, which may include software validation protocols and reports and/or other software development documentation.


• Other duties as assigned.


• Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• Bachelor’s Degree and 3+ years of professional work experience; OR,


• Master’s Degree and 1+ year(s) of professional work experience

Preferred Qualifications:

• Direct experience working with the Center for Devices and Radiological Health (CDRH), including writing and submitting pre-sub, IDE application and/or PMA documents to FDA and other health authorities


• Professional and/or academic experience:
  
  
  • interpreting scientific data, including clinical data
  
  
  • successfully managing multiple concurrent regulatory submissions
  
  
  • working cross-functionally on complex projects involving assay, instrumentation and software
  
  
  • attending meetings with FDA
  
  


• Experience with companion diagnostics


• Expertise in regulatory strategy


• Regulatory compliance knowledge of FDA IVD requirements and understanding of validation design typical for FDA IVD submissions


• Familiarity with device design control process and regulatory role in process


• Outstanding interpersonal skills that include excellence in written communication, oral communication, negotiation, collaboration and problem-solving


• Strong attention to detail and organizational skills


• Understanding of HIPAA and the importance of patient data privacy


• Commitment to reflect FMI’s values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $101,440 - $126,800 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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