Quality and Regulatory Affairs Director

3 days ago

Cambridge, Massachusetts, United States Aspire Life Sciences Search Full time

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 company's 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 II–III 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

  • 8+ years of experience in Quality and Regulatory Affairs within medical devices.
  • Direct, hands-on experience interacting with the FDA (required).
  • Experience with ophthalmology devices (highly desirable but not essential).
  • Experience with De Novo submissions (nice to have).
  • Proven expertise with 21 CFR Part 820, ISO 13485, IEC 60601, and IEC 62304.
  • Demonstrated ability to build or scale QMS systems in start-up or growth-stage environments.
  • Strong track record leading regulatory submissions, audits, and cross-functional alignment.
  • Excellent communication, leadership, and problem-solving skills.
  • Start-up mindset: agile, hands-on, and comfortable operating in a fast-growing, resource-lean environment.

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.

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