Description
We are looking for a
Medical Device Senior Technical Expert (m/f)
Reference: -en
Start: 09/16
Duration: 4 MM
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Gap assessment across the company's biologics medical device portfolio
- Contribute to the gap assessment of DHF, in accordance the FDA Part 4 regulations and 21 CFR 820.30 as Subject Matter Expert in either purchasing controls or risk management or product and process development or CFR 211 DP requirements (part of CFR4) or product control or change control or post market surveillance
Your qualifications
- Senior expert in medical device development and combination products
- Knowledge about devices (e.g. syringe, auto-injectors etc.)
- Auditing experience is beneficial
- Master degree in science/engineering or mechanical engineering or university level engineering education
- Excellent English skills
Skills:
- Project manager