Additional Location(s): US-MN-Maple Grove; N/A
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.
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: 633322Minimum Salary: $155000Maximum Salary: $294500The 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.
