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 re