We are seeking an experienced and driven QA/RA Manager with a strong Design Assurance focus to join an exciting early-stage medical device company at a pivotal point in their growth journey. This is a rare opportunity to play a lead role in bringing a genuinely life-changing product to market — a catheter-based device designed to improve quality of life for patients in palliative care.

Working within a passionate, fast-moving start-up environment, you'll take ownership of design control processes, drive regulatory compliance, and act as a key bridge between R&D and quality as the company accelerates from Phase 2 to Phase 4 over the next 18 months. If you thrive in an environment where your work truly matters and where no two days are the same, this is the role for you.

Key Responsibilities include but are not limited to the following:

• Lead and maintain Design Control processes in compliance with FDA 21 CFR Part 820, ISO 1...