Director of Quality Assurance & Regulatory Affairs (Salary £80-90k)
Location: Middlesex, UK
Our client, a global leader in reproductive health technology, designs and manufactures advanced cryopreservation and incubation equipment for fertility clinics worldwide.
They are seeking an experienced QARA leader to drive global quality and regulatory strategy, oversee product registrations and approvals, and ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other standards.
You'll embed quality from concept to delivery, lead audits, maintain the QMS, manage regulatory documentation, and guide a skilled QARA team. Applicants should have proven QARA leadership in medical devices or other regulated industries, a strong engineering background, and expertise in CE marking, UK/EU regulations, electrical safety, software validation, and global compliance.
This is a chance to shape the regulatory future of innovative medical devices transforming fertility care worldwide, in a collaborative, mission-driven environment.
Please send a CV if interested to hear more