Global Regulatory Affairs MedTech– 897221 MS

Location
Canton of Solothurn
Salary
Competitive
Posted
09 Feb 2021
Closes
24 Feb 2021
Ref
897221 MS
Hours
Full Time
Contract Type
Permanent
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.