RA Manager

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.

Job Responsibilities:

• 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.

Key Skills:

• Good organizational skills and a strong sense of personal responsibility.
• Customer-oriented and communicative personality.

Requirements:

• 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).

Apply now:

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.