Are you an experienced QA/RA leader ready to shape the future of wound care? A pioneering MedTech start-up is seeking a Quality Assurance and Regulatory Affairs Manager to drive global regulatory strategy and quality systems for an innovative Advanced Tissue Repair Platform targeting chronic and complex wounds.
This is a rare opportunity to join a fast-paced, lean start-up environment where you’ll work hands-on to establish scalable, compliant systems and contribute directly to patient impact. The ideal candidate will bring deep experience in medical device development (especially durable medical equipment) and working knowledge of regenerative therapies, including synthetic biodegradable polymers and combination products.
Key Responsibilities:
* Build and maintain a robust QMS (ISO 13485, FDA 21 CFR Part 820)
* Lead design control, risk management (ISO 14971), and post-market surveillance
* Define and execute global regulatory strategies (FDA, CE Mark, MDR, etc.)
* Prepare and submit regulatory submissions (510(k), IDE, PMA)
* Serve as regulatory liaison with FDA, notified bodies, and global authorities
* Oversee supplier and contract manufacturer compliance
* Support clinical/preclinical strategy from a regulatory perspective
You’ll Bring:
* 8–10+ years in QA/RA roles within the medical device space
* Strong background in DME and regenerative medicine
* Hands-on experience with successful FDA PMA and EU MDR submissions
* Strategic leadership skills with a roll-up-your-sleeves attitude
* A startup mindset: proactive, adaptable, and resourceful
What’s on Offer:
* Build the regulatory and quality foundations of a disruptive MedTech platform
* Competitive salary + equity
* Flexibility and high-growth potential
If you're looking to make a real-world impact while leading from the front in a mission-driven startup, we want to hear from you.
Apply now or message for a confidential chat.