Additional Location(s):US-MN-Maple Grove; US-MN-Arden Hills; US-MN-Minneapolis Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About the role Boston Scientific is seeking a strategic and visionary leader to serve as Vice President of Regulatory Affairs and Health Economics and Market Access (HEMA) for the Interventional Oncology & Embolization (IO&E) division. This role will integrate global Regulatory Affairs and HEMA leadership to drive innovation, ensure compliance, and enable market access for transformative IO&E technologies.This leader will play a critical role on the IO&E leadership team and will have a direct impact on our business, strategies, and competitive landscape. Your responsibilities will include: Champion regulatoryand market accessstrategies that promotetimelyworldwideapproval,adoptionand reimbursementof IO&E productsincluding medical devices, drug/device combination products, and pharmaceuticals. Develop andmaintainprograms, policies, and procedures ensuring compliance with international and governmental regulatory standards. Lead regulatory due diligence for mergers, acquisitions, and partnerships with assessing regulatory strategy, risk, and compliance to inform investment decisions and integration planning. Lead a global Regulatoryand HEMAteam toaccomplishdivisional goals and strategies. Provideexpertisein interpreting regulations and drive implementation across the organization. Oversee regulatory aspects of field actions, recalls, and post market events, audits, ensuringtimelyand effective execution in alignment with global health authority requirements. Collaborate with cross-functional teams to develop clinical strategies and economic evidencedemonstratingvalue of IO&E technologies to support market access Engage withglobalpayers, providers, and policy makers to shape access and coverage policies. Ensure integration of HEMA insights into product development, commercialization, and lifecycle management. Drive innovative approaches todemonstratevalue and support health system decision-making. Represent Boston Scientific in interactions with regulatory authorities and industry associations. Collaborate with corporate, divisional, and regional partners to ensuretimelyproduct approvals and compliance. Lead a diverse, global team with complex initiatives;foster an inclusive, patient-centric culture and support career development across teams; attract andretainworld-class talent. Required qualifications: Bachelor's degreerequired;Advanced degree preferred. 15+years of experience in Regulatory Affairsand/or HEMAwithinthe pharmaceuticaland/ormedical device industry. 10+years of direct management experience leading global teams. Proven leadership in developing and executing globalRegulatory andHEMA strategies. Expertisein regulatory pathways including PMA,IDE,510(k), EU MDR,NDA, IND, FDA pre-submissionsand international registrationsincluding China and Japan. Demonstratedexpertisein global healthcare systems / markets and economics of healthcare reimbursementwitha focusonUShealthcare andCMS. Experience with device and combination products, specifically with cancer therapies. Established relationships with global regulators and payers. Demonstrated ability to influence key economics purchasers including customers, payers, and governments. Ability to interpret regulations and apply to business needs. Demonstrated understanding of commercial, operational, and functional aspects of the business and success in managing complex matrixed organizations and influencing cross-functional teams. Ability to travel domestically and/or internationally asrequired. Preferred qualifications: Strong leadership skills with high customer focus. High degreeofintegrity and professionalism. Ability to build relationships and influence internal and external stakeholders. Experience in IO&E or related interventional therapies is highly desirable. Requisition ID:618291 Minimum Salary: USD$215100 Maximum Salary: USD$408700 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com- will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including... For full info follow application link. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
