Description
We are looking for a
Medical Device Developer (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Apply mechanical engineering skills to create effective medical devices
- Develop mathematical and statistical models to understand the impact of primary packaging attributes on drug administration
- Provide high quality input and documentation for the interaction with regulatory authorities
- Apply your knowledge of the regulatory landscape to ensure standard compliant designs, compilation of Design History File, verification, validation and manufacture support, working according to Quality Management Systems such as ISO 13485 and 21CFR820 and risk management according to ISO 14971
Your qualifications
- Profound experience in mechanical engineering and primary packaging development
- Deep knowledge of parenteral drug container and delivery (including devices such as pre-filled syringes, auto-injectors, needle safety devices)
- Sound analytical skills
Skills:
- Clinical data manager
Keywords: Clinical Data Manager