Global Regulatory Affairs MedTech– 897221 MS

Canton of Solothurn
11 Feb 2021
13 Mar 2021
897221 MS
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Our client is a leading company in Switzerland. It is headquartered in Central Switzerland. The Company has a global network of production sites, subsidiaries and marketing and sales partners. For our client, we are looking for two Regulatory Affairs Managers.

Main Responsibilities:

  • Management of regulatory approvals for medical devices worldwide with a focus on the USA, China and the EU
  • Design and maintenance of registration documents
  • 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.
  • Supervision of development projects relating to regulatory affairs
  • Assessment of amendments
  • Negotiation of contracts with customers regarding Regulatory Affairs aspects

Qualifications and Experience:

  • Professional Completed university degree, preferably in natural sciences or engineering (ETH / FH) or equivalent training
  • Min 4-5 years of 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
  • Good organizational skills and a strong sense of personal responsibility
  • Customer-oriented and communicative personality
  • Confident German language skills mandatory
  • Very good knowledge of English (level C2 or mother tongue)
  • Well-groomed and expressive communication style;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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