Head of Quality Assurance and Regulatory Affairs

What you’ll do:

• Lead the development and implementation of regulatory and quality assurance strategies, ensuring compliance with MDR, FDA, and other international medical device regulations.
• Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team, setting clear priorities, working directly alongside stakeholders, and building a lean, high-performance culture that adapts as Ada’s regulatory and quality needs evolve.
• Act as an internal SME (Subject Matter Expert) on regulatory requirements, industry trends, and compliance best practices, as required.

What you’ll bring:

• At least four years of professional experience in regulatory affairs or quality management systems related to software as a medical device (SaMD).
• Demonstrated ability to design and scale a lean QMS appropriate for a Series B/C startup, with a track record of cutting waste, improving efficiency, and enabling the business to move quickly without compromising compliance.
• Strong expertise in EU MDR and in-depth knowledge of EN ISO 13485 is essential.

What’s awaiting you at Ada:

• Flexible working hours to maintain a healthy work/life balance.
• 28 days holiday, plus bank holidays to unplug, rest and recharge for our UK employees (30 days plus public holidays in Germany).
• Corporate health insurance and pension scheme (UK).