Cure Talent are delighted to be partnered with a global medical device company at the forefront of developing advanced technologies that support clinicians and healthcare providers worldwide. As they continue to expand their innovative portfolio and international presence, we have an exciting opportunity for a Director of Quality Assurance & Regulatory Affairs to join their UK leadership team.
As the new Director of QARA, you will play a pivotal role in shaping and delivering the company's global quality and regulatory strategy. This is a senior leadership position with responsibility for ensuring compliance across a diverse product portfolio, enabling market access, and embedding quality excellence throughout the product lifecycle.
To be successful as the Director of QARA, you will be an experienced medical device professional with proven leadership in Quality Assurance and Regulatory Affairs. You will bring a strong engineering background, expertise in ISO 13485, MDR and FDA compliance, and a track record of managing international submissions and inspections. Alongside your technical knowledge, you will be a confident communicator with the ability to influence at senior level, develop teams, and embed a culture of compliance and continuous improvement.
Key Responsibilities
* Lead and implement the company's global QARA strategy in line with business and compliance objectives.
* Oversee international product registrations, submissions, CE marking and approvals.
* Maintain and continuously improve the Quality Management System to ISO 13485, MDR and FDA standards.
* Host regulatory inspections and lead internal and supplier audit programmes.
* Mentor and develop the QARA team, embedding a culture of compliance and continuous improvement.
Experience and Skills Required
* Proven leadership in Quality Assurance and Regulatory Affairs within medical devices or regulated industries.
* Strong engineering background with expertise in CE marking, EU/UK MDR, FDA and international submissions.
* Hands-on experience with audits, inspections and QMS management.
* Skilled in electrical safety, software validation and global compliance requirements.
* Excellent communication, stakeholder engagement and team development skills.
If you're an experienced QARA leader ready to shape the regulatory future of innovative medical technologies and drive quality excellence on a global scale, we'd love to hear from you.