Vice President, Regulatory Affairs and Health Economics and Market Access - IO&E

Additional Location(s): N/A Diversity

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• 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 regulatory and market access strategies that promote timely worldwide approval, adoption and reimbursement of IO&E products including medical devices, drug/device combination products, and pharmaceuticals. Develop and maintain programs, 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 Regulatory and HEMA team to accomplish divisional goals and strategies. Provide expertise in interpreting regulations and drive implementation across the organization. Oversee regulatory aspects of field actions, recalls, and post market events, audits, ensuring timely and effective execution in alignment with global health authority requirements. Collaborate with cross-functional teams to develop clinical strategies and economic evidence demonstrating value of IO&E technologies to support market access Engage with global payers, 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 to demonstrate value 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 ensure timely product approvals and compliance. Lead a diverse, global team with complex initiatives; foster an inclusive, patient-centric culture and support career development across teams; attract and retain world-class talent.

Required qualifications:

Bachelor's degree required; Advanced degree preferred. 15+ years of experience in Regulatory Affairs and/or HEMA within the pharmaceutical and/or medical device industry. 10+ years of direct management experience leading global teams. Proven leadership in developing and executing global Regulatory and HEMA strategies. Expertise in regulatory pathways including

PMA, IDE, 510

(k), EU

MDR, NDA, IND, FDA

pre-submissions and international registrations including China and Japan. Demonstrated expertise in global healthcare systems / markets and economics of healthcare reimbursement with a focus on US healthcare and CMS. 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 as required.

Preferred qualifications:

Strong leadership skills with high customer focus. High degree of integrity 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 without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of

COVID-19

vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the

COVID-19

vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to

COVID-19

vaccination.