Global Regulatory Compliance Director

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

Additional Location(s): US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

About the role:

Boston Scientific is seeking a Global Regulatory Compliance Director, Internal Audit for its Global Quality Systems group. The purpose of this role is to provide strategic leadership, governance, and stewardship of the GRC internal audit team, the global internal audit process, and the Internal Audit Community of Practice.

The Global Regulatory Compliance Director will work as part of a broad, global team within the Global Quality System and partner with site, divisional, regional, and corporate Quality leadership to identify compliance risks, strengthen internal controls, and drive sustained audit readiness across the BSC network.

The Global Regulatory Compliance Director will set the vision for a risk-based internal audit program that supports adherence to the BSC Quality System and applicable global regulations. They will ensure the internal audit process is strategically governed, effectively maintained, and continuously improved in support of Corporate and Site quality objectives.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Your Responsibilities Will Include

• 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.

Required 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

Preferred Qualifications

• Advanced degree
• Experience working with or within an external notified body, competent authority, or regulatory agency
• Pharmaceutical or combination-product experience
• Digital product