Director of Compliance

A leading healthcare company dedicated to placing patients at the centre of everything it does is seeking a seasoned and visionary Director of Compliance to lead and integrate all compliance functions (Quality Assurance, Regulatory Affairs, Sustainability, and Legal). They have a strong international presence and an expanding portfolio of cutting-edge products. The organisation is driven by a mission to enhance patient outcomes through continuous innovation and operational excellence. Reporting to the C-Suite, this senior leadership role ensures that all operations, products, and services comply with applicable industry regulations, legal requirements, and quality standards. The successful candidate will help position the organisation to achieve its global growth ambitions while enabling innovation within a robust compliance framework.

Responsibilities:

• Lead the Compliance function across Quality Assurance, Regulatory Affairs, Sustainability, and Legal.
• Provide strategic direction to embed compliance as a value driver across innovation, production, and expansion.
• Develop and implement compliance strategies aligned with corporate goals.
• Advise senior leadership on regulatory trends and emerging risks.
• Lead cross-functional compliance initiatives.
• Champion compliance as a catalyst for patient innovation and business growth.
• Stay current on regulatory frameworks including UK Medical Device Regulations, EU MDR, FDA standards, ISO standards, and sustainability legislation.
• Present complex compliance matters to senior stakeholders clearly and effectively.
• Lead audits and ensure timely implementation of corrective actions.
• Oversee global regulatory strategy and ensure compliance with all relevant regulations.
• Manage submissions for new and existing products, including technical documentation and clinical evaluations.
• Maintain relationships with regulatory bodies and resolve issues proactively.
• Develop and execute the organization’s sustainability strategy.
• Drive cross-functional sustainability programs to support long-term ESG goals.
• Oversee sustainability governance and reporting frameworks.
• Encourage collaboration on reducing environmental impact.
• Manage legal compliance for products, services, operations, and governance.
• Oversee legal risk, including IP, liability, and data protection (e.g., GDPR).
• Liaise with external legal counsel and ensure documentation aligns with regulatory needs.
• Design and maintain compliance training across the organization.
• Promote a culture of compliance and continuous improvement.
• Establish systems for regulatory monitoring and internal reporting.
• Report compliance metrics and risks to leadership and the Board.
• Maintain comprehensive records of compliance activities.

Requirements:

• Degree in Life Sciences, Engineering, Law, or related field.
• Strong knowledge of international regulatory frameworks (e.g., MDR, MDSAP, FDA, ISO 13485).
• Proven success in obtaining regulatory approvals (FDA, CE, etc.).
• Experience managing global compliance teams and working with Notified Bodies.
• Ability to influence senior leaders and boards on complex compliance issues.
• Experience leading sustainability compliance and integrating ESG principles.
• Strong communication skills, with the ability to explain technical topics to diverse audiences.
• Familiarity with ESG monitoring, sustainability projects, and AI-enabled regulatory tools.
• Legal expertise in IP, product liability, and contract law within the medical device or healthcare sector.

Please reach out to emily.james@skillsalliance.com for further details.