Director RA/QA Compliance

EPM Scientific; Marlborough (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

EPM Scientific partners with a leading global medical device manufacturer to hire a Global Director of Regulatory Compliance. The role provides strategic leadership for global audit and compliance programs within Quality Systems, driving enterprise-wide initiatives and ensuring readiness for regulatory inspections.

In this high-visibility position, you will lead a global team, develop risk-based internal audit strategies, monitor evolving regulatory requirements, and collaborate with senior

Qualifications

• 10+ years in Medical Device Quality and/or Regulatory Compliance.
• Deep expertise in global quality systems and audit programs.
• Strong knowledge of FDA regulations, ISO 13485, EU MDR, and other international standards.
• Proven leadership experience in complex, global organizations.
• Ability to influence stakeholders and drive strategic initiatives across functions.

Responsibilities

• Lead a global team responsible for quality system auditing and compliance activities.
• Develop and execute a risk-based internal audit strategy across global operations.
• Drive continuous improvement initiatives and strengthen quality system effectiveness.
• Partner with cross-functional leaders to identify, assess, and mitigate compliance risks.
• Support global regulatory inspections and external audits.
• Monitor changing regulatory requirements and implement proactive compliance strategies.

Skills

Regulatory leadership

Quality systems

Global auditing

Regulatory strategy

Stakeholder influence

Job description

A leading global medical device manufacturer is seeking a Global Director of Regulatory Compliance to provide strategic leadership for its global audit and compliance programs within Quality Systems.

In this highly visible leadership role, you will drive enterprise-wide compliance initiatives, oversee a global internal audit program, and partner with senior stakeholders to ensure inspection readiness and adherence to evolving global regulatory requirements.

Requirements:

• Lead a global team responsible for quality system auditing and compliance activities
• Develop and execute a risk-based internal audit strategy across global operations
• Drive continuous improvement initiatives and strengthen quality system effectiveness
• Partner with cross-functional leaders to identify, assess, and mitigate compliance risks
• Support global regulatory inspections and external audits
• Monitor changing regulatory requirements and implement proactive compliance strategies

Qualifications:

• 10+ years of experience in Medical Device Quality and/or Regulatory Compliance
• Deep expertise in global quality systems and audit programs
• Strong knowledge of FDA regulations, ISO 13485, EU MDR, and other international standards
• Proven leadership experience in complex, global organizations
• Ability to influence stakeholders and drive strategic initiatives across functions

About the Role:

A leading global medical device manufacturer is seeking a Global Director of Regulatory Compliance to provide strategic leadership for its global audit and compliance programs within Quality Systems.

In this highly visible leadership role, you will drive enterprise-wide compliance initiatives, oversee a global internal audit program, and partner with senior stakeholders to ensure inspection readiness and adherence to evolving global regulatory requirements.

Requirements:

• Lead a global team responsible for quality system auditing and compliance activities
• Develop and execute a risk-based internal audit strategy across global operations
• Drive continuous improvement initiatives and strengthen quality system effectiveness
• Partner with cross-functional leaders to identify, assess, and mitigate compliance risks
• Support global regulatory inspections and external audits
• Monitor changing regulatory requirements and implement proactive compliance strategies

Qualifications:

• 10+ years of experience in Medical Device Quality and/or Regulatory Compliance
• Deep expertise in global quality systems and audit programs
• Strong knowledge of FDA regulations, ISO 13485, EU MDR, and other international standards
• Proven leadership experience in complex, global organizations
• Ability to influence stakeholders and drive strategic initiatives across functions

This is an outstanding opportunity to join a market-leading medical device organization and play a critical role in shaping global compliance strategy and quality excellence.