Job Summary

We have an exciting opportunity for a Head of Quality Assurance and Regulatory Affairs role in a Medical Equipment Manufacturing company. The company develops smart wearable technology. It is looking for an experienced individual who can understand and respond to client needs and difficulties while leading a small, focused team in a fast‑paced startup environment.

Requirements

• A bachelor's degree in a science or engineering discipline is required.
• Extensive expertise in the biotech/medical device industry, with an emphasis on IVD.
• Working knowledge of medical equipment classified as Class I and Class II.
• Excellent ability to communicate.
• 7+ years of combined Quality Assurance, Regulatory, and Clinical Affairs expertise.
• Experience working in a mid‑sized or start‑up environment is required.
• Established solid working relationships with regulatory agencies.
• Capable of organising, priorit...