Global Regulatory Compliance Director

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, communicate, 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 OR minimum of 10 years working within an external notified body or regulatory agency
• 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
• 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

Requisition ID: 636569 

Minimum Salary: $ 162400 

Maximum Salary: $ 308600 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.