Director of QA/RA

Walker Cole International is supporting a leading wound care medical device company the North West in the search for a Director of Quality & Regulatory Affairs (QARA) to provide strategic leadership across Quality and Regulatory functions. This permanent position will play a critical role in ensuring compliance with global regulatory requirements, maintaining high-quality standards, and supporting the continued growth of the business.

As the QARA Director, you will be responsible for:

• Developing and leading the company’s Quality and Regulatory strategy across the woundcare portfolio.
• Ensuring compliance with MDR, FDA 21 CFR Part 820, ISO 13485, and other applicable international standards.
• Leading Quality Management System (QMS) development, implementation, and continuous improvement.
• Overseeing regulatory submissions, approvals, and lifecycle management for woundcare products across global markets.
• Acting as the primary contact with notified bodies, regulatory agencies, and external auditors.
• Driving a culture of quality and compliance across the business through leadership, training, and mentoring.
• Collaborating with R&D, Manufacturing, and Commercial teams to align regulatory and quality requirements with business objectives.
• Monitoring changes to regulatory frameworks and industry standards, ensuring proactive compliance and readiness.

The ideal candidate will have:

• Proven leadership experience in a senior Quality and Regulatory Affairs role within the medical device industry, ideally woundcare or related therapeutic areas.
• In-depth knowledge of EU MDR, FDA 21 CFR Part 820, ISO 13485, and international medical device regulations.
• Strong track record of successful regulatory submissions and approvals in EU, US, and global markets.
• Demonstrable experience managing and improving Quality Management Systems.
• A degree in life sciences, engineering, or a related discipline.
• Excellent leadership, communication, and cross-functional collaboration skills.

Desirable experience:

• Previous experience as the company representative in regulatory inspections and audits.
• Familiarity with post-market surveillance, vigilance, and clinical evaluation requirements.
• Experience driving quality and compliance in a growing, innovation-driven business.

Quality & Regulatory Affairs | QARA Director | Medical Devices | Woundcare | MDR | FDA 21 CFR 820 | ISO 13485 | Regulatory Submissions | Quality Management Systems | Notified Body | Regulatory Strategy | Compliance Leadership | EU MDR | Global Submissions | Post-Market Surveillance | Lifecycle Management