Fellow, Regulatory Affairs

Fellow, Regulatory Affairs

Work mode:
Hybrid Onsite Location(s):
Maple Grove, MN, US, 55311 Additional Location(s): US-MN-Maple Grove; US-MA-Marlborough; US-MN-Arden Hills 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 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. We are seeking an experienced Regulatory Affairs Fellow to provide strategic leadership in navigating the evolving U.S. medical device regulatory landscape and strengthening relationships with European Notified Bodies. In this highly influential role, you will lead regulatory policy, intelligence and external engagement initiatives while supporting enterprise-wide Notified Body collaboration and governance.

You will partner across Regulatory Affairs, Quality, Government Affairs, Legal and business teams to anticipate regulatory changes, influence policy discussions and strengthen strategic relationships that support timely patient access to innovative medical technologies.

Work model, sponsorship:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. This role may be based in Arden Hills or Maple Grove, Minnesota, or Marlborough, Massachusetts. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Strategic Notified Body relationships and governance
• Regulatory policy, intelligence and advocacy
• Cross-functional collaboration and influence

Qualifications:

Required qualifications:

Bachelor's degree in engineering, life sciences, regulatory affairs or a related technical or scientific discipline, or an equivalent combination of education and directly relevant professional experience. Minimum of 8 years' experience in regulatory affairs or a related discipline within medical devices, pharmaceuticals or combination products, including significant experience in regulatory strategy, policy interpretation and external regulatory engagement. Expert-level knowledge of U.S. Food and Drug Administration (FDA) medical device regulations, regulatory pathways, guidance development and the broader U.S. regulatory policy environment.

Strong working knowledge of European medical device regulations, particularly EU MDR, Notified Body processes and conformity assessment requirements. Demonstrated experience influencing regulatory strategies, policies or decisions within a complex, global organization. Experience participating in or leading regulatory policy committees, industry trade associations or external advocacy initiatives. Experience developing industry policy positions, regulatory comment letters or advocacy strategies.

Preferred qualifications:

Proven ability to lead cross-functional initiatives and influence senior stakeholders without direct reporting authority. Exceptional analytical, strategic thinking, negotiation, communication and executive presentation skills. Ability to interpret complex regulatory and policy developments and translate them into actionable business strategies. Established relationships or demonstrated experience engaging with the FDA, European Notified Bodies and medical device industry organizations. Demonstrated experience in enterprise regulatory governance, regulatory intelligence or strategic external relationship management.