Senior Manager Regulatory Affairs

Genomic Health is the world's leading provider of personalized genomic analysis of tumor biopsies. With our highly successful Oncotype DX assay for breast cancer and our pipeline of additional assays in development, we are passionate about our mission of improving the quality of treatment decisions for patients with cancer. We have an exciting opportunity for a talented and experienced Senior Manager Regulatory Affairs. - The Senior Manager of Regulatory Affairs will be responsible for the coordination and preparation of U.S. regulatory submissions, both 510(k) and PMA. - Oversee the implementation of strategies for earliest possible approvals of products through the 510(k) and PMA process. - Direct and oversee the preparation of all required documentation for submission to appropriate governmental regulatory agencies. - Facilitate proposed regulation and advise on impact of such regulations to Genomic Health. - Review and recommend changes to labeling, manufacturing documents, marketing information and clinical protocols for regulatory compliance. - Works with project teams and external advisors (including FDA) to identify appropriate regulatory pathways for new product registrations, and provides advice to applicable company personnel regarding the regulatory aspects associate with these activities. - Develops and implements regulatory strategy for projects which complement the commercial, operational and market strategies for the product. - Interact with company partners and consultants for various regulatory matters as needed. - Demonstrate a high ethical standard, with big picture and systems thinking in the best interests of Genomic Health. - Demonstrates knowledge of CLIA Regulations - Demonstrates ability to answer and/or defend sponsor submissions successfully at face-to-face meetings with regulatory agencies including the FDA. - Demonstrates knowledge in the design and process of clinical trials to GMP, including regulatory requirements, data collection and analysis, and preparation of regulatory submissions including 510(k)'s. - Demonstrates ability to interpret FDA and other regulatory agency regulations and guidelines, and to convert these in practical and pragmatic advice to non-regulatory colleagues. - A proven track record in preparing Premarket Notifications, IDE's and PMA's, which were successfully cleared/approved by the FDA. - Excellent people skills. Sound verbal, written and presentation skills. - Ability to work in teams and focus on success. - Ability to organize, plan and prioritize activities - B.S. degree in a scientific, engineering or medical field. Advanced degree preferred. - Seven to ten years of Regulatory experience, with at least five years within IVD environment - PMA experience preferred. If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=492195-3-223 Reference Code: 1173 View all "Genomic Health" jobs