Vice President, Regulatory Affairs & Quality Systems

Organization
Freenome
Job Location
201 Gateway Blvd
South San Francisco, CA 94080
Benefits

Health, vision, dental, and flexible vacation policy.

Job Description

Freenome’s Vice President, Regulatory Affairs & Quality Systems will lead, manage and implement regulatory and quality strategy for the organization. You will join a high impact team that takes innovative approaches to curing age-related disease.  We develop new software, technology, science, and medicine with leading experts from each field.  If you are interested in building a strong intellectual community and you want to help be a part of treating cancer, come talk to us!

Please apply here! - https://jobs.lever.co/freenome/e8d3acea-e4c6-43cf-a6da-f370e46a5731/apply

RESPONSIBILITIES

    • Responsible for development and implementation of product regulatory strategies and plans for submissions to FDA, and other regulatory authorities, as appropriate
    • Lead interactions with the FDA, CAP, NYSDOH, and international agency personnel to expedite approval of pending applications and resolve regulatory matters
    • Partner with other functional leaders including Quality Assurance, R&D, Clinical Operations, to develop, implement, and improve quality systems
    • Ensure compliance with the FDACode of Federal Regulations, the European in Vitro Diagnostic Directives/regulations, EN 13485 and other International Quality Standards as appropriate.  This includes, but is not limited to, country specific licenses, the design input, review, out-put and verification, validation, transfer and change control.
    • Direct the compilation of device master records, technical files, design dossiers, FDA and European submission documents, and/or any other relate documents/reports, ensuring timely submissions to CDRH, etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses.
    • Review submissions for completeness, accuracy, verification of analytical and clinical data, and compliance with submission standards and expectations
    • Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment, and regulatory precedent
    • Ensure alignment of regulatory strategy to business strategy across all functional areas
    • Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
    • Ensure employees understand and comply with the requirements of cGMP as applied to the Company’s product(s). Provide related training and support to departments as needed
    • Provide regulatory due diligence and regulatory advice for potential new product opportunities
Requirements

ABSOLUTE REQUIREMENTS

    • Bachelor degree in a life science discipline such as chemistry or biology, with some education in genetics
    • Track record in successful FDA and ROW premarket submissions and registrations
    • At least 5 years of experience in some combination of a molecular testing laboratory, a diagnostic manufacturing organization and/or a diagnostics service organization
    • At least 5 years working in a regulatory affairs department engaged with direct negotiations with the FDA in resolving issues with submissions
    • At least 3 years managing a FDA regulated quality system and has been a part of developing a new quality system from scratch
    • Experience preparing and submitting successful 510(k)s and PMAs and an understanding of the multiple 510(k) routes to clearance of a diagnostic product
    • Outstanding oral and written presentation and communication skills

 ABOVE THE AVERAGE

    • Advanced degree in a life science discipline such as chemistry or biology, with some education in genetics
    • Experience leading the regulatory function in an organization
    • Experience with regulatory and quality system requirements for laboratory-developed tests
    • Experience with regulatory registrations outside the US and EU   

  

About Our Organization

Freenome (free•nohm) is the dynamic collection of genetic material floating in your blood (cell-free) derived from the trillions of cells in your body. It is your living cell-free genome changing over time and space. Your freenome is the genomic thermometer of who you are as you grow, live, and age. Our platform allows you to track the health of your freenome so you can make the best decisions for you. Your freenome helps you design your “healthy" and then serves as a warning system for “unhealthy" conditions such as cancer so that you can get the care that you need, when you need it.
It is precision wellness - for your freenome - for your health.

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