Global Regulatory Compliance & Internal Audit Director

Boston Scientific; Marlborough (MA); Híbrido; USD 162.000 - 309.000; Jornada completa

Descripción de la vacante

Boston Scientific is seeking a Global Regulatory Compliance Director, Internal Audit for its Global Quality Systems group. This role leads the GRC internal audit program, governs the global audit process, and partners with site, divisional, regional, and corporate Quality leadership to identify risks and drive audit readiness.

The position requires a strategic thinker who can set a vision for a risk-based internal audit program, maintain governance, and continuously improve processes in support

Formación

• Bachelor’s degree required.
• 10+ years in Medical Device Quality Systems or auditing roles.
• Strong knowledge of ISO 13485, 21 CFR 820, EU MDR and related standards.
• Inclusive leadership of global teams and senior stakeholders.
• Willingness to travel up to 25% domestically and internationally.

Responsabilidades

• Lead and develop a global team of quality system auditors and leaders.
• Define multi-year internal audit strategy aligned with enterprise quality priorities.
• Oversee identification, documentation, and remediation of significant quality nonconformances.
• Govern the Internal Audit process with governance, metrics, and priorities.
• Drive the Internal Audit Community of Practice across sites and regions.
• Sponsor CAPA and continuous improvement initiatives to strengthen compliance.
• Ensure external audit readiness and support for global procedures.
• Deliver measurable process improvements and year-over-year savings targets.
• Stay current with regulatory changes affecting the Global Quality System.
• Collaborate with site, divisional, regional teams and corporate Quality leadership.

Conocimientos

Strategic leadership

Global team leadership

Audit strategy

Regulatory knowledge

Travel up to 25%

Educación

Bachelor’s degree

Descripción del empleo

Boston Scientific is seeking a Global Regulatory Compliance Director, Internal Audit for its Global Quality Systems group. This role leads the GRC internal audit program, governs the global audit process, and partners with site, divisional, regional, and corporate Quality leadership to identify risks and drive audit readiness.

The position requires a strategic thinker who can set a vision for a risk-based internal audit program, maintain governance, and continuously improve processes in support