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Global Regulatory Compliance Senior Manager at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Mar, 26

Salary

0.0

Posted On

27 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality System Auditing, Regulatory Compliance, Team Management, Process Improvement, Problem Solving, ISO 13485, 21 CFR 820, EU MDR, Leadership, Analytical Skills, Communication Skills, Training, Technical Tools, Continuous Improvement, Medical Device Experience, Pharmaceutical Experience, Digital Product Ownership

Industry

Medical Equipment Manufacturing

Description

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. 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

Responsibilities

Manage and develop a team of quality system auditors while supporting the audit team in identifying significant quality system nonconformances. Facilitate external audits and deliver process improvements to achieve multimillion-dollar savings goals.