Global Regulatory Compliance Senior Manager

Boston Scientific • Arden Hills, MN

10d

About The Position

Your responsibilities will include: 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. Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs. Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture. 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. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Requirements

• 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
• Strong analytical and communication skills

Nice To Haves

• Advanced degree
• Pharmaceutical experience
• Digital product ownership and/or IT project experience

Responsibilities

• 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.
• Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs.
• Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• 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.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees