Manager, Regulatory Affairs

Boston, MA, United States

Job Description

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. The incumbent functions as the regulatory representative on cross-functional teams as well as prepares and submits packages to the FDA for approval of new products or new companion diagnostic indications. The position actively supports the development of regulatory strategy focused on the use of NGS technology for companion diagnostic assays for cancer patients. Additionally, 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 Us

Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

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)