RA Manager

6 days left

Location
Emmental, Switzerland, Burgdorf
Salary
£99946.80 - £124933.50 per annum
Posted
03 Feb 2021
Closes
03 Mar 2021
Ref
BBBH15860
Contact
Chloe McCormack
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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.

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