Global Regulatory Affairs MedTech– 897221 MS
- Company
- CTC Resourcing Solutions
- Location
- Canton of Solothurn
- Salary
- competitive
- Posted
- 11 Feb 2021
- Closes
- 13 Mar 2021
- Ref
- 897221 MS
- Discipline
- Project Management, Regulatory Project Management, Regulatory Affairs, Compliance, Regulatory Writing
- 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.
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