Sr Director Regulatory Affairs MedTech for LCI

Sr. Director, Regulatory Affairs - MedTech for the Lung Cancer Initiative (LCI) & Interventional Oncology Location: Raritan, New Jersey; Bay Area, California; however, flexible arrangements for other US site locations can be discussed At J&J, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. The Lung Cancer Initiative (LCI), a cross-sector initiative, is charged by the Executive Committee of J&J with meaningfully altering the course of lung cancer and improving survival by preventing, intercepting, and curing lung cancer. The LCI strives to eliminate lung cancer one patient at a time by developing comprehensive solutions through consumer products, diagnostics, medical devices, and pharmaceuticals. As the lead for MedTech, the Sr RA Director plays a key role in ensuring that regulatory strategies are established and implemented in service of the LCI. Is this you? If yes, APPLY. https://www.jnj.com/credo/ Key Responsibilities: Provide leadership, guidance, interpretation, and opinions on complex regulatory matters (particularly related to submission pathways), outlining the potential outcomes for different regulatory strategies, and setting the strategy for submissions of product registration documents to health authorities Provide regulatory expertise and knowledge of regulatory requirements to develop regulatory strategic plans for cross-sector and cross-platform projects Partner with MedTech Franchise and Platform RA leadership teams to ensure robust, optimum regulatory strategies are established and in service of LCI Drive collaboration within MedTech and with cross-functional partners and serves a critical role as the MedTech RA lead to make the connections across disparate priorities Develop and carry out the governance model for MedTech RA LCI related activities and strategies, including cross-platform ways of working Serve as the counterpart to the Pharm RA LCI Lead Assist in the design of clinical studies required for regulatory approvals Monitor and analyze regulatory agency activities in areas of interest to the LCI and assess the potential impact on LCI programs. Take a global view of regulatory strategy and help teams navigate regional requirements and the possible interplay between key regulatory agencies. Examine Global regulatory strategy options, provide relevant guidance/precedents, and stay abreast of the regulatory and competitive landscape. Qualifications Required Advanced degree in a Sciences discipline, MD or equivalent 12 or more years of hands-on Regulatory Affairs experience in Medical Devices; five (5) years of progressive leadership experience Extensive knowledge and experience in designing and implementing regulatory and clinical strategies, and submission logistics Demonstrated track record of success in leading all areas of regulatory affairs from early-stage experience (clinical-first into human study) and IDE through pre-market or approval process Expertise in working effectively with the FDA and Notified Bodies to obtain approvals in the US and EU Balance of strategic thinking and strong analytical skills with the ability to effectively execute Detail oriented and results driven with strong written, verbal communication and presentation skills Domestic and or internationally travel up to 20 percent Preferred Oncology experience and knowledge Experience with international regulatory submissions Combination devices with an emphasis in oncology Highlighted Benefits Competitive and Equitable Compensation Long Term Incentives (LTI) Benefits such as health, vacation, holidays, personal & family paid time off etc. Travel Health Pension Plan Johnson & Johnson is an Affirmative Action, and Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability Primary Location United States-California-Redwood City-150 Shoreline Dr Organization Auris Health, Inc. (6267) Job Function Regulatory Affairs Requisition ID 2206083621W