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Associate Director of Regulatory Affairs

Apply Share Job ID 860 Category Quality Assurance/Regulatory Job Location Redwood City, California Posted Date 04/21/2018

Overview:

The Senior Program Manager of Regulatory Affairs is responsible for leading the program deliverables on behalf of the Genomic Health Inc's Regulatory Affairs department. You will be responsible for implementing local (U.S.) and International product registration strategies and must have a demonstrated, successful experience with preparing, reviewing and submitting regulatory submissions to regulatory bodies like FDA, European competent authorities and notified bodies, Health Canada, SFDA, KFDA, MHLW etc. for approval/clearance. Additional demonstrated experience operating in a highly regulated environment and proven application of analytical skills, plus project management skills, ability to prioritize, plan and execute deliverables for established program goals is required. Key interactions include Senior Management, Executive Staff, and development team personnel plus outside regulatory representatives. This position reports to the Senior Director of Regulatory Affairs.

The ideal candidate will have a minimum of 2 years as a Manager in Regulatory Affairs (medical device, pharma or IVD industry) with a track record of successfully PMA approvals and/or 510(k) clearances as well as international approvals.


RESPONSIBILITIES / DUTIES:
·Responsible for implementation of product regulatory strategies.
·Successful development, review and submission of local and international regulatory submissions, inclusive of pre-submission briefing packages and meetings, 510(k), PMA, Notified Body review of CE-IVD Technical Files.
·Direct interactions w/ FDA & international agency personnel to facilitate approval of pending applications & resolve regulatory matters.
·Direct development team/program participation aimed at achieving marketing authorization and competitive, appropriate product labeling and fostering business growth in target markets.
·Partner with other functional program participants including Quality Assurance, R&D, Clinical Operations, to facilitate timely develop, implement, and improve quality systems, write procedures, etc.
·Ability to manage others is preferable.
·Ability to establish and maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines and keeping management informed

QUALIFICATIONS:
Bachelor degree in a life sciences field required.
·Advanced degree in a technical field preferred.
·Minimum of 5 years of experience as Regulatory Affairs Manager/Sr Manager - IVD industry highly preferred.
·Minimum of 12 years Regulatory Affairs experience, preferably within the IVD/medical device industry.
·Background in molecular diagnostics preferred.
·Demonstrated working understanding & knowledge applying medical device/IVD regulations of FDA and International regulations (ideally including EU).
·Results-driven and team-oriented with an enthusiastic attitude and strong interpersonal skills.
·Team player with excellent verbal and written communication skills, project management, problem-solving, risk management, and presentation skills.
·Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing

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The ideal candidate will have a minimum of 2 years as a Manager in Regulatory Affairs (medical device, pharma or IVD industry) with a track record of successfully PMA approvals and/or 510(k) clearances as well as international approvals.
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!