Foundation Medicine · 19 hours ago
Associate Director, Regulatory Affairs (CDx)
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$175K/yr - $219K/yr
6+ years expFoundation Medicine is focused on providing molecular insights to physicians for cancer treatment. The Associate Director, Regulatory Affairs is responsible for developing regulatory strategies and managing submissions for regulatory approvals of diagnostic products.
BiotechnologyGeneticsHealth CareMedical
Responsibilities
Manage premarket 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 Foundation Medicine 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 Foundation Medicine 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
Qualification
Required
Bachelor's Degree and 8+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field, OR
Master's Degree in science, law, health policy, regulatory affairs or engineering and 6+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field OR
Doctorate Degree in science, law, health policy, regulatory affairs or engineering and 3+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field
4+ years of management experience
Experience in regulatory affairs
Preferred
8+ year of regulatory experience
Ability to understand and interpret clinical data
Expert understanding of FDA promotional regulations and reports on post marketing requirements
Excellent oral and written communication and negotiation skills with strong attention to detail and clarity
Ability to interact effectively and influence across relevant functions within Ipsen and with regulators
Demonstrate understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standards
Recognized as a leader, team player, and possess a cross-functional collaborative skill set
Ability to manage multiple activities or projects
Understanding of HIPAA and the importance of patient data privacy
Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for Foundation Medicine's benefits.
Company
Foundation Medicine
Foundation medicine is a molecular information company developing clinical diagnostic tests that facilitates personalized cancer therapies.
1001-5000 employees
H1B Sponsorship
Foundation Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (41)
2023 (30)
2022 (36)
2021 (41)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$96.5MKey Investors
Kleiner Perkins
2015-01-12Acquired
2013-09-25IPO
2013-01-08Series B· $13.5M
Leadership Team
Daniel Malarek
Chief Executive Officer
David Fabrizio
VP, Commercial Strategy and Medical Innovation
Recent News
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