Quality and Regulatory Affairs Director (Cambridge)

Our client is a fast-growing MedTech start-up based in Boston, developing next-generation ophthalmology devices. With clinical milestones progressing, FDA interactions underway, and an ambitious commercial roadmap, they are entering a critical phase of scaling and are now looking to hire a Director of Quality & Regulatory Affairs.

The role

As Director of Quality & Regulatory Affairs, you will serve as the senior leader responsible for shaping and executing the companys quality and regulatory strategy. You will build, strengthen, and manage an ISO 13485-compliant QMS suitable for high-risk ophthalmic devices, oversee FDA submissions, and drive compliance across product development and clinical activities.

Key responsibilities

• Build, implement, and improve an ISO 13485-compliant QMS suited for ophthalmic Class IIIII devices.
• Define and execute the regulatory strategy for FDA submissions, including 510(k), De Novo (nice to have), and pre-submission interactions.
• Lead all communications with the FDA and serve as the regulatory authority within the company.
• Ensure ongoing compliance with FDA 21 CFR Part 820, IEC 60601, IEC 62304, and other relevant standards.
• Partner closely with R&D, clinical, and manufacturing teams to guide design controls, risk management, verification / validation, and documentation.
• Oversee quality operations including CAPA, NCR, supplier management, audits, and PMS activities.
• Manage and grow a small QA / RA team, providing mentorship and leadership.
• Support U.S. market entry and long-term regulatory planning as the company scales.
• Operate with a start-up mindset : hands-on, proactive, and comfortable building processes from scratch.

Required experience and qualifications

Your consultant

As a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons specialises in Quality and Regulatory Affairs recruitment across the MedTech sector in Europe and the United States. Taylor partners with innovative, high-growth companies to identify and engage experienced leaders who can drive compliance, innovation, and operational excellence. With deep knowledge of regulatory expectations and the evolving MedTech landscape, Taylor focuses on building long-term partnerships that deliver real impact.