Global Regulatory Affairs MedTech– 897221 MS

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.