Cure Talent are delighted to be partnered with an emerging wearable medical technology company at a defining stage of its growth. Developing next-generation optical monitoring solutions designed to deliver medical grade physiological insights beyond the hospital environment, the business is now transitioning from research and development into industrialisation and regulated market entry.
We have an opportunity for a RAQA Manager to establish and lead the Quality and Regulatory function at a pivotal point in the company’s journey.
As the RAQA Manager, reporting to the Chief Operating Officer, you will take ownership of implementing and achieving ISO 13485 certification from first principles, while defining and driving the US regulatory strategy for initial market clearance, anticipated via a 510k submission. Following US approval, the role will support expansion into European and other international markets.
This is a strategically critical role, central to enabling commercialisation and investor confidence.
This position is inherently hands-on. You will operate as the sole QARA professional initially, embedding Design Control, risk management and regulatory structure into a product environment moving from innovation to regulated manufacture. The scope offers long-term progression potential as the organisation scales and builds out its Quality and Regulatory capability.
To be successful as the new RAQA Manager, you will bring proven experience building and certifying ISO 13485 systems within a MedTech start-up or scaling environment. You will be confident leading FDA submissions, comfortable interacting directly with the FDA, and capable of defining a clear US regulatory pathway aligned to product development timelines, with an understanding of European regulatory pathways including CE marking.
You will combine technical regulatory depth with pragmatic judgement, ensuring compliance is integrated into development without compromising pace or innovation.
Key Responsibilities
* Implement and achieve ISO 13485 certification for the organisation.
* Define and lead the US regulatory strategy and 510k submission programme.
* Support future regulatory strategy and submissions for European and other international markets, including CE marking.
* Embed Design Control and risk management into product development activities.
* Develop and maintain Technical Documentation aligned to regulatory requirements.
* Build the Quality infrastructure required to support industrialisation and commercialisation.
Experience and Skills Required
* Proven Regulatory Affairs and Quality experience within medical devices.
* Demonstrated experience implementing and certifying an ISO 13485 Quality Management System.
* Experience preparing and leading FDA submissions and interacting with regulatory authorities.
* Strong understanding of US regulatory requirements including 21 CFR Part 820 and QMSR.
* Experience operating within start-up or high-growth MedTech environments.
* Strong knowledge of Design Control and Risk Management principles.
* Understanding of European regulatory pathways and CE marking is advantageous.
* Degree in a relevant scientific or engineering discipline is advantageous but not essential.
This is a high-impact opportunity within a growing wearable MedTech business where regulatory strategy and quality leadership are fundamental to product approval and commercial success. It will suit a QARA professional who enjoys ownership, building systems from the ground up and playing a defining role in bringing innovative technology to market.