Regulatory Affairs Manager (German speaker)

Details

  • Category: Medical devices
  • Location: Solothurn area
  • Starting date: Mar 01, 2021
  • Domain of experience: Regulatory Affairs
  • Level required: Specialist
  • Years of experience: 5 years

Your Role

Within the Quality Management & Regulatory Affairs (RA) division, you will act as RA Manager. Your main mission will be to manage Medical Devices approvals worldwide with a focus on the US, China and the EU.

Your Tasks

  • Implement approvals for Medical Devices worldwide with a focus on the US, China and the EU
  • Create and maintain documents’ registration
  • Supervise projects development relating to regulatory affairs
  • Assess regulatory amendments
  • Negotiate contracts with customers regarding RA aspects
  • Assure the correspondence with authorities for inquiries and reports from authorities
  • Assist customer and authority audits according to ISO 13485 and 21 CFR 820
  • Manage general QM tasks such as training, creation of Q documents, etc.

Your Profile

  • Completed university degree, preferably in natural sciences or engineering (ETH / FH)
  • At least 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 high degree of personal responsibility
  • Customer-oriented and communicative personality
  • Confident German language skills
  • Very good knowledge of English (level C2 or mother tongue)
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