About the Job

The Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory approval process 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 health authorities for approval of new products or new indications for use. The incumbent will actively support the development of regulatory strategy focused on the use of NGS technology for companion diagnostic assays for cancer patients. The incumbent may also be responsible for leading a team. This position partners closely with product development teams and external partners focused on development of genomic biomarkers and companion diagnostic indications.

Key Responsibilities

• Manage premarket submissions for regulatory approval of in vitro companion diagnostic medical devices, including the US and EU markets.
• 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 and IVDR 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.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree AND 5+ years of regulatory experience in the device, pharmaceutical/biologics, biotech, or other life science industry (including 3+ years in regulatory affairs) OR
• Advanced Degree (Master's or Doctorate) in science, engineering, regulatory affairs, health policy or closely related field AND 4+ years of experience in regulatory affairs

Preferred Qualifications

• Industry experience in oncology, CDx, NGS, IVD, CAP/CLIA
• Experience interacting with health authorities, including FDA
• Experience managing and mentoring junior personal
• Expert understanding of FDA regulations
• Strong knowledge of IVDR and PMDA regulatory processes
• Ability to interact effectively and influence across relevant functions within FMI, with regulators, and with external partners
• Ability to understand and interpret scientific data
• History of effective time management, organization, and prioritization of multiple concurrent projects
• History of proactive and independent problem solving
• Technical background in next generation sequencing technologies
• Strong attention to detail and organizational skills
• Strong collaborative skill set, demonstrated by creative and effective contributions in cross-functional or cross-departmental partnerships 
• Demonstrated ability to meet project deadlines
• Excellent interpersonal skills including strong written and verbal communication, collaboration, and problem solving with a variety of audiences
• Understanding of HIPAA and importance of patient data privacy
• Commitment to FMI’s values: innovation, patients, collaboration, and passion

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