Cure Talent are delighted to be partnered with an innovative medical technology company developing advanced wearable and AI-driven healthcare solutions. As they continue to expand their global regulatory footprint, we have an exciting opportunity for an RAQA Manager to join their growing team.
As the new RAQA Manager, you will take ownership of regulatory compliance and market access activities across UKCA, FDA, and upcoming CE marking, while overseeing the Quality Management System in line with ISO 13485 and FDA 21 CFR Part 820. The role also includes line management of one team member, offering an excellent opportunity to shape both regulatory and quality strategy across the business.
Key Responsibilities
* Maintain existing UKCA and FDA submissions and lead CE marking activities.
* Prepare, update, and manage regulatory documentation and technical files.
* Liaise with regulatory authorities, notified bodies, and external stakeholders.
* Oversee the Quality Management System in compliance with ISO 13485, MDR, and FDA 21 CFR Part 820.
* Manage internal and supplier audits, CAPA, NCR, change control, and risk management activities.
* Maintain document control and training records in line with regulatory requirements.
* Line manage and mentor one direct report.
Experience and Skills Required
* Proven Regulatory Affairs and Quality experience within the medical device industry.
* Strong knowledge of UKCA marking, CE marking, and FDA 510(k) submissions.
* In-depth understanding of ISO 13485, MDR, and FDA 21 CFR Part 820.
* Experience leading or supporting audits and inspections.
* Knowledge of risk management, change control, and product lifecycle processes.
* Experience with MDSAP, UDI, or PMS activities is advantageous.
* Familiarity with connected medical devices or digital health technologies is desirable.
* Previous line management or mentoring experience preferred.
If you’re an experienced RAQA professional seeking a dynamic role where you can lead both regulatory and quality activities in an innovative medical technology environment, we’d love to hear from you.