Mgr, Regulatory Affairs at Foundation Medicine, Inc. in Boston, Massachusetts

Job Description:

• Full Time

About the Job

The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. FMI’s products include diagnostic assays that provide molecular insights to physicians to guide treatment options for cancer patients. The incumbent functions as the regulatory representative on cross-functional teams and will be preparing and submitting packages to the FDA for approval of new products or new companion diagnostic indications. The incumbent will actively support the development of regulatory strategy focused on the use of NGS technology for companion diagnostic assays for cancer patients. This position partners closely with product development teams and external partners focused on development of genomic biomarkers and companion diagnostic indications.

Key Responsibilities

• Manage pre-market submissions for regulatory approval of in vitro companion diagnostic medical devices in the US market.
• Develop regulatory strategy with oversight for complex projects, including internal FMI projects as well as biopharma partner projects.
• Develop and implement regulatory strategy for non-clinical product development and clinical development.
• Provide regulatory support for currently marketed products, e.g., review engineering changes, labeling, promotional material, product change control documentation to ensure compliance with federal regulations and health authority guidance, including for changes requiring regulatory agency approval or notification, as pertains to US regulatory requirements.
• Represent FMI in interactions with external partners for companion diagnostic development or support for partner drug filings.
• Review and edit technical documents to be included in submission, which may include validation protocols and reports and/or other development documentation.
• Author regulatory submission documentation, including SRDs, IDEs, and PMAs.
• Ensure that software and data products are developed and validated to standards required for FDA-regulated products and/or for data included as part of a drug or diagnostic regulatory submission (e.g. SRDs, IDEs, Pre-Submissions, PMA).
• Acquire and maintain current knowledge of applicable regulatory requirements, scientific and technical issues in the discipline as relevant to assigned projects.
• Interpret and apply FDA regulations and guidance documents to business practices, evaluating risk and proposing solutions to business challenges based on regulatory strategy.
• Interface with regulatory authorities on regulatory and technical matters as directed, including lead meetings with the regulatory authorities.
• Manage and mentor junior members of the Regulatory Affairs Team.
• Represent Regulatory Affairs department at cross-functional internal project meetings.
• May perform other duties as required or assigned.

Qualifications:

Basic Qualifications:

• Bachelor’s Degree and 4+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field, OR
• Advanced Degree (Master’s or Doctorate Degree) in science, law, health policy, regulatory affairs or engineering and 2+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field
• Experience in regulatory affairs

Preferred Qualifications:

• 2+ years of experience in regulatory affairs within the life sciences industry
• Experience:
  • interpreting and applying FDA guidance and regulations
  • interfacing with the FDA (e.g., CDRH), including submissions (e.g., SRDs, IDEs, PMAs) and with pre-submission meetings
  • preparing and managing IDE and PMA submissions
  • with genomic data analysis, especially in a regulated environment
• Industry experience in oncology, NGS, IVD, CDx, CAP/CLIA, and/or regulatory
• Understanding of the principles of scientific, engineering, physiology and medical device use
• History of effective time management, organization, prioritization and multitasking
• History of proactive and independent problem solving
• Strong collaborative skill set, demonstrated by creative and effective contributions in cross-functional or cross-departmental partnerships
• Demonstrated organization, attention to detail and high level of accuracy
• Effective and clear oral and written communication skills, and negotiation skills
• Demonstrated ability to:
  • prepare and present information to groups
  • interact effectively across relevant functions
  • manage multiple activities or projects
  • work in a fast-paced/entrepreneurial environment
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration

#LI-Hybrid

About Foundation Medicine

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)

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