Job Description
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,...