Global Regulatory Compliance Director, Internal Audit

Boston Scientific; Marlborough (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Boston Scientific is seeking a Global Regulatory Compliance Director, Internal Audit for its Global Quality Systems group. The role provides strategic leadership of the GRC internal audit program across the global network, partnering with site, divisional, regional, and corporate Quality leadership to identify risks and strengthen controls.

The director will set the vision for a risk-based internal audit program, ensure governance and continuous improvement, and support external audit readiness

Qualifications

• Minimum of Bachelor’s degree in a relevant field.
• Minimum of 10 years of Medical Device Quality Systems experience, including extensive experience leading or overseeing internal and/or external audit programs.
• Strong understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.).
• Demonstrated inclusive leadership skills with experience leading, developing, and influencing global teams and senior stakeholders
• Ability to travel up to 25% domestically and internationally

Responsibilities

• Lead, coach, and develop a global team of quality system audit leaders and auditors responsible for executing the Corporate audit schedule and global risk-based audit strategy.
• Define and deploy the multi-year internal audit strategy in partnership with Quality leaders across the BSC network, ensuring the audit program is data-driven, risk-based, and aligned with enterprise quality priorities.
• Provide strategic oversight and escalation support for the identification, documentation, communication, and remediation of significant quality system nonconformances against external regulations and internal SOPs/WIs.
• Serve as the 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 drive alignment, standardization, and best-practice sharing across sites, divisions, and regions.
• Sponsor auditor capability building, training strategy, technical tools, digital enablement, and continuous improvement efforts that strengthen a preventive quality culture.
• Assess changes to standards, regulations, and regulatory expectations applicable to the assigned area, determine potential impact to 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 necessary to improve global processes and sustain compliance.
• Champion departmental, cross-functional, and enterprise quality initiatives that advance compliance, audit readiness, and Quality System effectiveness.
• Apply sound, systematic problem-solving and executive decision-making methodologies to identify, prioritize, communication, and resolve complex quality and compliance issues.

Skills

Inclusive leadership

Global team leadership

Regulatory understanding

Audit program management

Problem solving

Education

Bachelor's degree in a relevant field

Job description

Boston Scientific is seeking a Global Regulatory Compliance Director, Internal Audit for its Global Quality Systems group. The role provides strategic leadership of the GRC internal audit program across the global network, partnering with site, divisional, regional, and corporate Quality leadership to identify risks and strengthen controls.

The director will set the vision for a risk-based internal audit program, ensure governance and continuous improvement, and support external audit readiness