We recruited for a Director of Quality & Regulatory Affairs for a fast-growing MedTech start-up developing next-generation ophthalmology devices. The role served as the senior leader responsible for shaping and executing the company’s quality and regulatory strategy during a critical phase of clinical progress, FDA interaction, and company scaling.

The position involved building and managing an ISO 13485-compliant Quality Management System for high-risk ophthalmic devices, leading FDA regulatory strategy and submissions (including 510(k) and pre-submissions), and ensuring compliance with key standards such as FDA 21 CFR Part 820, IEC 60601, and IEC 62304. The role worked closely with R&D, clinical, and manufacturing teams to support design controls, risk management, verification and validation, and documentation processes.

The role also oversaw quality operations including CAPA, audits, supplier management, and post-market surveillance, while building and mentoring a small QA/RA team and supporting U.S. market entry and long-term regulatory planning. The position required significant experience in medical device quality and regulatory affairs, direct FDA interaction experience, and experience building or scaling QMS systems in start-up or growth-stage environments.