Regulatory Affairs Specialist
A multinational life science company is seeking a Regulatory Affairs Specialist to join their office in Zuchwil, Switzerland. This is a contract role.
- Project-specific support the internal Regulatory Affairs team in creation and maintenance of Technical Documentation for CE marked products (implants and instruments) according to Council Directive 92/42/EEC and Medical Device Regulation 2017/745.
- Creation of Technical File Summary Reports, Essential Requirements Checklists, General Safety and Performance Requirements Checklists, List of Applied Standards
- Reviewing of and providing input for Clinical Evaluation Reports, Risk Management, Labeling
- Creating and Maintaining of data sets that support Technical Documentation creation, maintenance and sustainability
- Support registration activities in G9 countries, EMEA, APAC, LAT and US
Education, Skills and Experience:
- Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC and Medical Device Regulation 2017/745
- 2-3 years' experience in European Medical device Industry especially within regulatory, labeling, quality or engineering.
- Familiarity with Technical Documentation structure according to STED and as required by Medical Device Regulation 2017/745
- Experience with PLM systems such as Windchill PLM, Agile e6 PLM, preferred
- Technically versed in computer software such as MS Word, Powerpoint.
- Strong skills in MS Excel essential
- Strong database skills (Access, SQL) desired
- Strong analytical skills and network thinking
- English spoken and written, German in addition would be desired
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Andrea on +44 203 854 0675 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.