Global Regulatory Compliance Director

Boston Scientific•Marlborough, MA

2d•Hybrid

About The Position

Boston Scientific is seeking a Global Regulatory Compliance Director, Internal Audit, for its Global Quality Systems group. The role provides strategic leadership, governance, and stewardship for the GRC internal audit team, global internal audit process, and Internal Audit Community of Practice. Working with site, divisional, regional, and corporate Quality leaders, the director identifies compliance risks, strengthens internal controls, and promotes sustained audit readiness across the Boston Scientific network. The director sets the vision for a risk-based internal audit program supporting compliance with the BSC Quality System and applicable global regulations. The role governs and maintains the internal audit process, improves it continuously, leads a global team, and supports Corporate and Site quality objectives. The position follows a hybrid work model requiring at least three days per week in the local office and requires up to 25% domestic and international travel. The role also provides executive leadership for external audit readiness and execution, sponsors auditor development and digital enablement, assesses regulatory changes, and drives measurable process improvements and savings. The director may sponsor or own corrective and preventive actions (CAPAs) and champion quality initiatives across the organization.

Requirements

Bachelor's degree in a relevant field.
At least 10 years of Medical Device Quality Systems experience, including extensive experience leading or overseeing internal and/or external audit programs, or at least 10 years working within an external notified body or regulatory agency.
Strong understanding of regulations and standards applicable to the BSC Global Quality System, including ISO 13485, 21 CFR 820, and EU MDR.
Demonstrated inclusive leadership skills and experience leading, developing, and influencing global teams and senior stakeholders.
Ability to travel up to 25% domestically and internationally.
High degree of integrity and professionalism, with the ability to establish credibility internally and externally, including with senior leaders and regulators.
High sense of urgency, strategic judgment, and commitment to execution in a complex global environment.

Nice To Haves

Advanced degree.
Pharmaceutical or combination-product experience.
Digital product ownership, data analytics, audit technology, and/or IT project experience.
Strong executive presence, analytical capability, and communication skills.

Responsibilities

Lead, coach, and develop a global team of quality system audit leaders and auditors responsible for the Corporate audit schedule and global risk-based audit strategy.
Define and deploy a multi-year internal audit strategy with Quality leaders across the BSC network, ensuring it is data-driven, risk-based, and aligned with enterprise quality priorities.
Provide strategic oversight and escalation support for identifying, documenting, communicating, and remediating significant quality system nonconformances against external regulations and internal SOPs/WIs.
Serve as global process steward and accountable leader for the Internal Audit process, including governance, process performance, health metrics, and strategic priorities.
Own the internal audit strategic process roadmap and lead the Internal Audit Community of Practice to promote alignment, standardization, and sharing of best practices across sites, divisions, and regions.
Sponsor auditor capability building, training strategy, technical tools, digital enablement, and continuous improvement to strengthen a preventive quality culture.
Assess changes to applicable standards, regulations, and regulatory expectations, determine their potential impact on BSC, and sponsor projects to ensure continued compliance.
Provide executive leadership for external audit readiness and execution, including front room and back room governance, SME preparation, storyboard strategy, and site-level support for Global procedures.
Deliver measurable process improvements through the VIP model and oversee year-over-year savings and productivity commitments against multimillion-dollar goals.
Sponsor and, when appropriate, act as CAPA owner for corrective actions and systemic improvements that improve global processes and sustain compliance.
Champion departmental, cross-functional, and enterprise quality initiatives that advance compliance, audit readiness, and Quality System effectiveness.
Use systematic problem-solving and executive decision-making to identify, prioritize, communicate, and resolve complex quality and compliance issues.