Fellow, Regulatory Affairs

Regulatory Affairs Fellow

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.

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.

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

• Serve as the primary corporate liaison with European Notified Bodies, including BSI, DEKRA, TÜV and GMED, establishing and maintaining strategic relationships with their leadership teams.
• Lead enterprise-wide Notified Body governance, including performance monitoring, issue escalation, risk identification and executive reporting.
• Establish and lead governance forums, monthly account meetings, annual strategic reviews and internal certification and strategy alignment meetings.
• Oversee meeting agendas, executive communications, decisions, action items and follow-up activities while identifying systemic issues, emerging risks and opportunities for process improvement.
• Coordinate engagement between enterprise stakeholders and divisional Regulatory Affairs, Quality and business teams to address emerging challenges and opportunities.
• Monitor developments in the European conformity assessment landscape and assess potential business implications.
• Promote best practices and consistency in Notified Body engagement across the organization.
• Drive cross-divisional alignment on certification priorities, EU Medical Device Regulation (EU MDR) implementation, regulatory expectations and engagement strategies.
• Influence Notified Body interpretations and decisions through evidence-based technical and regulatory discussions that promote consistent, predictable and risk-proportionate outcomes.
• Oversee Notified Body terms, service agreements, fees, invoicing and performance expectations in partnership with Quality, Legal, Procurement, Finance and leadership to improve the efficiency, predictability and transparency of certification processes.

Regulatory policy, intelligence and advocacy

• Serve as Boston Scientific's strategic lead for U.S. medical device regulatory intelligence, providing oversight of emerging requirements, policy developments and external regulatory trends.
• Monitor and evaluate emerging legislation, regulations, regulatory guidance, policies and industry trends, with a primary focus on the United States.
• Analyze regulatory developments and communicate potential business implications, risks and opportunities to stakeholders and senior leadership.
• Deliver timely regulatory intelligence and strategic recommendations…