Global Regulatory Compliance Senior Manager

Additional Locations: US-CA-Valencia; US-CA-San Jose; US-IN-Spencer; US-MN-Arden Hills; US-MN-Maple Grove

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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 advance your skills and career. Here, you’ll be supported in progressing—whatever your ambitions.

Boston Scientific is seeking Global Regulatory Compliance Senior Manager & Internal Audit Quality Steward for its Global Quality Systems group. The purpose of this role is to provide strong leadership & stewardship of the GRC audit team and internal audit process & Community of Practice.

The GRC Manager will work as part of a broad, global team within the Global Quality system and particularly with all site and divisional Quality leadership to identify any gaps in compliance with internal and external requirements.

• Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk‑based audit schedule.
• Partner with Quality leaders across the BSC network (sites, divisions, and regions) to ensure a high level of compliance by developing and deploying a data‑driven, risk‑based audit schedule.
• Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs.
• Act as the sub‑process steward for the global Internal Audit process.
• Lead the development and ownership of the strategic process roadmap as well as ownership of the internal audit community of practice.
• Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
• Facilitate external audits through leadership in audit front rooms, back rooms, training for SME’s, creation of storyboard material and site level support for Global procedures.
• Deliver process improvements through the VIP model with year over year savings against a multimillion‑dollar yearly goal.
• Act as a CAPA owner for corrective actions necessary to improve the global processes.
• Champion departmental or cross‑functional quality initiatives.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Minimum of Bachelor’s degree in relevant field
• Minimum of 10 years of Medical Device Quality Systems experience including extensive experience auditing
• Understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.).
• Demonstrated inclusive leadership skills
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally
• High sense of urgency and commitment to execution
• Ability to travel up to 25 - 30% domestically and internationally

• Advanced degree
• Pharmaceutical experience
• Digital product ownership and/or IT project experience
• Strong analytical and communication skills

Requisition

Minimum Salary: $127900

Maximum Salary: $243000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see  – 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.

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 identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.