Global Regulatory Compliance Director

Boston Scientific; Arden Hills (MN); On-site; USD 162,400 - 308,600; Full time

Job summary

Boston Scientific seeks a Global Regulatory Compliance Director for its Global Quality Systems group in Arden Hills, Minnesota. This role involves leading strategic governance for the internal audit team, focusing on audit readiness and compliance across the network.

The ideal candidate should have a minimum of 10 years of experience in Medical Device Quality Systems and possess a solid understanding of regulatory standards. This position operates in a hybrid work model, requiring in-office presence three days a week.

Qualifications

• Minimum of 10 years of Medical Device Quality Systems experience.
• Experience leading internal and/or external audit programs.
• Strong understanding of regulations applicable to Global Quality Systems.

Responsibilities

• Lead a global team of quality system audit leaders and auditors.
• Define and deploy an internal audit strategy.
• Oversee executive leadership for external audit readiness.

Skills

Leadership skills

Regulatory knowledge (ISO 13485, 21 CFR 820, EU MDR)

Analytical capability

Problem-solving methodologies

Education

Bachelor’s degree in a relevant field

Job description

Location: US‑MN‑Arden Hills

About the role

Boston Scientific seeks a Global Regulatory Compliance Director, Internal Audit for its Global Quality Systems group. The role leads the strategic governance of the GRC internal audit team, the internal audit process, and the Internal Audit Community of Practice, partnering with site, divisional, regional, and corporate quality leaders to strengthen controls and audit readiness across the network.

Key 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 a multi‑year internal audit strategy in partnership with Quality leaders across the network, ensuring the audit program is data‑driven, risk‑based and aligned with enterprise priorities.
• Provide strategic oversight and escalation support for the identification, documentation, communication and remediation of significant quality system non‑conformances 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 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 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, communicate and resolve complex quality and compliance issues.

Required Qualifications

• Minimum of a 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 ownership, data analytics, audit technology and/or IT project experience.
• Strong executive presence, analytical capability and communication skills.
• High degree of integrity, professionalism and 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.

Work arrangements

This role follows a hybrid work model requiring employees to be in the local office at least three days per week.

Compensation

Compensation range: $162,400 – $308,600.

Legal and EEO Statement

Boston Scientific is an equal‑opportunity employer and does not discriminate on the basis of race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran status, age, disability, genetic information or any other protected class.

COVID‑19 vaccination may be required for this safety‑sensitive role, and a prohibited substance test will be required.