Regulatory and Quality Director

Regulatory and Quality Director

Are you a seasoned professional with extensive experience in regulatory affairs and quality assurance within the medical device or pharmaceutical industry? Our Client, a leading organisation committed to innovation and excellence in healthcare, is seeking a strategic and dynamic Regulatory and Quality Director to lead their compliance and quality initiatives. This is a unique opportunity to influence global regulatory strategies and uphold the highest standards of quality across diverse markets.

About Our Client

Operating at the forefront of the medical device and healthcare sector, Our Client prides itself on fostering a culture of innovation, integrity, and continuous improvement. Recognised for its commitment to excellence, the organisation offers a collaborative environment, supportive leadership, and the chance to be part of a growing, globally respected company dedicated to improving patient outcomes.

Role Summary

The appointment of a Regulatory and Quality Director is pivotal as part of the organisation’s strategic growth and compliance initiatives. The successful candidate will spearhead regulatory strategies, streamline quality management systems, and act as the organisation’s primary liaison with health authorities worldwide. This position offers a high-impact leadership role, shaping the organisation’s compliance landscape and supporting its mission to deliver safe and effective healthcare products.

Key Responsibilities

• Develop and execute comprehensive regulatory plans for both new and existing products, ensuring timely approvals across international markets.
• Oversee all submissions to regulatory bodies, managing communication and ensuring compliance with evolving standards.
• Lead the design and implementation of robust quality management systems aligned with international standards, including ISO 13485, MDSAP, and FDA QSR.
• Manage internal and external quality audits, driving corrective actions and continuous improvement.
• Provide leadership to the Regulatory and Quality teams, fostering a culture of excellence and professional development.
• Collaborate seamlessly with cross-functional teams to embed compliance and quality into all operational processes.
• Cultivate strong relationships with external stakeholders, including regulatory agencies, partners, and consultants, ensuring alignment on compliance matters.
• Identify potential regulatory risks and develop strategic mitigation plans.
• Design and deliver training programmes to elevate understanding of compliance requirements organisation-wide.

Essential Skills & Experience

• A minimum of 10 years’ experience in regulatory affairs and quality assurance within the medical device or pharmaceutical sectors.
• Proven success in managing regulatory submissions and securing approvals in multiple jurisdictions.
• Deep knowledge of global regulatory frameworks and quality standards such as ISO 13485, MDSAP, FDA QSR, and EU IVDR.
• Demonstrable leadership and team management capabilities, with an ability to inspire and develop staff.
• Broad understanding of manufacturing processes in a medical device environment.
• RAC certification or equivalent qualification would be advantageous.
• Strong organisational skills, with the ability to juggle multiple priorities and meet deadlines.

Desirable Skills & Experience

• Experience working with electronic quality management systems (eQMS).
• Past involvement in strategic planning and regulatory risk management.
• Excellent interpersonal and communication skills, capable of training and presenting to diverse audiences.

Join Our Client’s Team

If you are ready to take on this vital leadership role and make a tangible impact in healthcare innovation, we invite you to submit your CV for consideration.