Regulatory Affairs Senior Manager
Company: Disability Solutions
Location: Boston
Posted on: October 13, 2024
Job Description:
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
#LI-Hybrid
Keywords: Disability Solutions, Lynn , Regulatory Affairs Senior Manager, Executive , Boston, Massachusetts
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