Fellow, Regulatory Affairs

Boston Scientific•Maple Grove, MA

2d•Hybrid

About The Position

Boston Scientific is 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. The role leads regulatory policy, intelligence, and external engagement initiatives while supporting enterprise-wide Notified Body collaboration and governance. It partners with Regulatory Affairs, Quality, Government Affairs, Legal, Clinical, commercial, 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 employees to work from a local office at least three days per week. Boston Scientific will not offer or assume sponsorship of an employment visa for this position.

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

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; identify systemic issues, emerging risks, and opportunities for process improvement.
Coordinate engagement among enterprise stakeholders and divisional Regulatory Affairs, Quality, and business teams to address emerging challenges and opportunities.
Monitor developments in European conformity assessment 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 in partnership 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 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 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 that promote 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 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.