6 days left
- Experience Level
Hobson Prior are currently working with a top leader within pioneering technology who provide injections pens, autoinjectors and infusion systems to administer liquid drugs. This is an exciting permanent position based in Switzerland.
- Implementation of approvals for medical devices worldwide with a focus on the USA, China and the EU.
- Assessment of amendments.
- Creation and maintenance of registration documents.
- Supervision of development projects relating to regulatory affairs.
- Negotiation of contracts with customers regarding RA aspects.
- Correspondence with authorities for inquiries and reports from authorities.
- Assistance with customer and authority audits according to ISO 13485 and 21 CFR 820.
- General QM tasks such as training, creation of Q documents, etc.
- Good organizational skills and a strong sense of personal responsibility.
- Customer-oriented and communicative personality.
- Completed university degree, preferably in natural sciences or engineering (ETH / FH) or equivalent training.
- A minimum of 5 years professional experience in regulatory affairs, preferably in the life science industry.
- Experience with registration authorities in the USA (experience in China is an advantage).
- Experience with interactive medical products is an advantage.
- Confident German language skills.
- Very good knowledge of English (level C2 or mother tongue).
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
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