Fellow, Regulatory Affairs

Boston Scientific•Arden Hills, MN

9d•$125,800 - $239,000•Hybrid

About The Position

Boston Scientific is seeking an experienced Regulatory Affairs Fellow to provide strategic leadership on the evolving U.S. medical device regulatory landscape and strengthen relationships with European Notified Bodies. The role leads regulatory policy, intelligence and external engagement initiatives and supports enterprise-wide Notified Body collaboration and governance. It partners across Regulatory Affairs, Quality, Government Affairs, Legal and business teams to anticipate regulatory changes, influence policy discussions and support timely patient access to innovative medical technologies. The position may be based in Arden Hills or Maple Grove, Minnesota, or Marlborough, Massachusetts, and follows a hybrid work model requiring at least three days per week in a local office. Boston Scientific will not offer or take over sponsorship of an employment visa for this position at this time.

Requirements

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.
At least 8 years of 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. 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.

Nice To Haves

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.

Responsibilities

Serve as the primary corporate liaison with European Notified Bodies, including BSI, DEKRA, TÜV and GMED, and establish and maintain 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, 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 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 with Quality, Legal, Procurement, Finance and leadership.
Lead U.S. medical device regulatory intelligence, overseeing emerging requirements, policy developments and external regulatory trends.
Monitor and evaluate emerging legislation, regulations, regulatory guidance, policies and industry trends, primarily in 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 to inform business planning and executive decision-making.
Support development and execution of regulatory policy and advocacy strategies aligned with enterprise priorities.
Develop position papers, regulatory consultation responses, executive briefing materials and policy recommendations on critical regulatory topics.
Represent Boston Scientific in industry associations, regulatory working groups and external stakeholder engagements.
Build and maintain strategic relationships with regulators, industry partners, trade associations and other external stakeholders.
Advance initiatives promoting regulatory efficiency, global convergence, innovation and patient access to medical technologies.
Collaborate with Regulatory Affairs, Quality, Government Affairs, Legal, Clinical and commercial teams to align regulatory policy initiatives with business priorities.
Provide subject matter expertise in regulatory policy and Notified Body engagement to support strategic business initiatives.
Influence decisions and drive alignment across diverse global stakeholders without direct reporting authority.
Serve as a trusted adviser to leadership on regulatory policy, external engagement and emerging U.S. regulatory developments.