Global Internal Audit & Regulatory Compliance Director

Boston Scientific; Arden Hills (MN); Hybrid; 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

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.