Global Regulatory Compliance Director
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 of the GRC internal audit team, the global internal audit process, and the Internal Audit Community of Practice. Working with site, divisional, regional, and corporate Quality leaders across a broad global team, the director identifies compliance risks, strengthens internal controls, and drives sustained audit readiness across the Boston Scientific network. The director sets the vision for a risk-based internal audit program supporting adherence to the Boston Scientific Quality System and applicable global regulations. The role governs and maintains the internal audit process and continuously improves it in support of corporate and site quality objectives. The position follows a hybrid work model, requiring at least three days per week in the local office, and involves up to 25% domestic and international travel.
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; alternatively, at least 10 years working within an external notified body or regulatory agency.
- Strong understanding of regulations and standards applicable to the Boston Scientific Global Quality System, including ISO 13485, 21 CFR 820, and EU MDR.
- Demonstrated inclusive leadership, with experience leading, developing, and influencing global teams and senior stakeholders.
- Ability to travel up to 25% domestically and internationally.
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.
- High degree of integrity and professionalism, and 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.
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 Boston Scientific network, ensuring the program 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 and work instructions.
- Serve as global process steward and accountable leader for the Internal Audit process, including governance, 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 best-practice sharing 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 relevant standards, regulations, and regulatory expectations; determine potential impact to Boston Scientific and sponsor projects to maintain compliance.
- Provide executive leadership for external audit readiness and execution, including front-room and back-room governance, subject-matter-expert 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 corrective actions and systemic improvements, and act as CAPA owner when appropriate, to 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
