Director of Regulatory Compliance
Marlborough
Permanent
Negotiable
Regulatory
PR/601462_1793126535
Director of Regulatory Compliance
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.