Regulatory Affairs Senior Manager

hace 4 semanas

Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

About the Role

The Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, developing 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.

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.
  • 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.
  • Acquire and maintain current knowledge of applicable regulatory requirements, scientific and technical issues in the discipline as relevant to assigned projects.
  • Interface with regulatory authorities on regulatory and technical matters as directed.
  • Manage and mentor junior members of the Regulatory Affairs Team.

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.
  • Industry experience in oncology, CDx, NGS, IVD, CAP/CLIA.
  • Experience interacting with health authorities, including FDA.
  • 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.
  • 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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