Senior Fellow, Regulatory Affairs

Additional Location(s): US-MN-Maple Grove; N/A

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:

The Senior Fellow, Regulatory Affairs is a highly influential enterprise individual contributor responsible for advancing regulatory excellence and accelerating FDA approval pathways across Boston Scientific's Cardiology portfolio. This role serves as a strategic leader and trusted adviser, leveraging deep expertise in cardiovascular technologies, regulatory science and FDA engagement to improve regulatory outcomes, reduce approval timelines and build sustainable organizational capability.

Operating across franchises and functions, the Senior Fellow drives systemic improvements in submission readiness, regulatory strategy, evidence generation, agency engagement and regulatory execution. This role is accountable for creating repeatable frameworks, governance models and best practices that strengthen regulatory performance across priority programs.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

Work model, sponsorship, relocation:

This is a remote position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

Enterprise regulatory strategy and FDA acceleration

• Own and continuously evolve the enterprise FDA acceleration strategy for priority Cardiology programs.
• Identify opportunities to reduce submission-to-approval timelines while maintaining regulatory rigor and patient safety.
• Challenge teams to pursue the most effective regulatory pathways rather than relying on historical approaches.
• Develop strategic recommendations for premarket approval applications (PMAs), investigational device exemptions (IDEs), pre-submissions and other complex regulatory submissions.

Submission readiness and quality

• Lead independent submission readiness assessments to strengthen right-first-time quality.
• Anticipate reviewer concerns and evaluate evidence packages before submission.
• Establish common readiness standards and review mechanisms across franchises.
• Drive improvements that reduce deficiencies, avoidable review cycles and regulatory delays.

Regulatory metrics and operational excellence

• Establish and monitor portfolio-level regulatory key performance indicators, including submission readiness, FDA review cycle time, deficiency rates, time to response, approval timelines and root causes of delays.
• Create governance mechanisms that drive accountability and corrective action across businesses and functions.
• Measure and communicate the business impact of regulatory performance improvements.

Strategic FDA engagement

• Develop enterprise approaches for FDA interactions, including Q-Subs, pre-submission meetings, interactive reviews and escalation strategies.
• Embed FDA reviewer perspectives into product development, clinical strategy, statistics, manufacturing and labeling decisions.
• Improve organizational preparedness for high-risk regulatory interactions and reviews.

Capability building and organizational impact

• Institutionalize lessons learned from FDA interactions, approvals and deficiencies.
• Create reusable playbooks, decision frameworks, tools and training resources.
• Develop advanced regulatory capabilities across the Cardiology organization.
• Promote portfolio-wide adoption of best practices that improve regulatory outcomes.

Enterprise leadership and influence

• Serve as an independent expert who challenges assumptions, influences senior leaders and drives decisions on high-priority programs.
• Identify systemic barriers affecting regulatory performance and lead cross-functional solutions.
• Partner closely with Regulatory Affairs, Clinical, Research and Development, Quality, Medical Affairs, Operations, Health Economics and Market Access, and business leadership teams.
• Operate with significant autonomy and enterprise accountability without direct people-management responsibility.

Qualifications:

Required qualifications:

• Advanced degree in medicine, science, engineering, regulatory affairs, public health or a related discipline.
• Recognized expertise in cardiovascular medical devices and regulatory science.
• Deep knowledge of FDA Center for Devices and Radiological Health processes, PMA and IDE submissions, clinical evidence generation, benefit-risk assessments and life cycle management.
• Strong network across the medical device industry and among FDA cardiovascular thought leaders.
• Experience influencing or reviewing regulatory strategy for complex, high-risk medical technologies.
• Demonstrated ability to drive enterprise-wide change through influence, expertise and thought leadership.

Preferred qualifications:

• Previous experience as an FDA reviewer or significant experience interacting with FDA cardiovascular device review teams; previous direct employment with the FDA in a cardiovascular reviewer role is preferred but not required.
• M.D. or clinically relevant Ph.D.
• Expertise in real-world evidence, clinical trial design, outcomes research and evidence strategy.
• Experience developing enterprise frameworks, governance processes and organizational capability-building programs.
• Strong executive presence and demonstrated ability to influence senior leadership without formal authority.

Success measures:

Success in this role will be demonstrated through:

• Improved submission quality and readiness.
• Reduced avoidable FDA deficiencies and review cycles.
• Faster approval timelines and improved time to market.
• Adoption of enterprise regulatory frameworks and best practices.
• Measurable improvements in regulatory cycle-time metrics.
• Enhanced organizational capability and regulatory effectiveness across the Cardiology portfolio.

This Senior Fellow-level position is an enterprise individual contributor accountable for building and sustaining regulatory acceleration capabilities that create measurable business impact across the Cardiology portfolio.

Requisition ID: 633322

Minimum Salary: $155000 

Maximum Salary: $294500 

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

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.