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Regulatory Affairs Specialist

  • Gehalt: CHF75 - CHF80 per hour
  • Art der Stelle: Contract, Full-time
  • Ort: Solothurn
  • Berufsbereich: Other
  • Datum der Ausschreibung: 04.09.2018
  • Job ID: Solothurn
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Experis IT is Europe's leading IT&T recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations. On behalf of our client, one of the market leaders in the field of medical devices / pharmaceuticals, we are looking for a Regulatory Affairs Specialist.

This is a contracting position from the 10th of September 2018 until end of August 2020 (2 years). This position will support the internal Regulatory Affairs team with the 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


-Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC and Medical Device Regulation 2017/745
- 2-3 years of experience in European Medical device Industry especially within regulatory, labeling, quality or engineering.
-Familiar with Technical Documentation structure according to STED
- Technically versed: MS Word, PowerPoint.
- Strong skills in MS Excel
-Nice to have: strong database skills (Access, SQL)
-Nice to have: experience with PLM systems such as Windchill PLM, Agile e6 PLM

General information:

· Start date: 10.09.2018 (negotiable)
· End date: 31.08.2020

  • Work location: Solothurn, Switzerland
    · Workload: 100%
    · Travelling: Not required

If you are a result-oriented person who is currently looking for an exciting new position the job description applies to your skills, then we look forward to receiving your application!

If you aren't sure whether you should apply or have any questions, please call Virginia Belli Colon on +41 61 282 22 10.

Not the right job for you? Experis, the leading IT recruitment agency in Switzerland has many open jobs, just browse our website now to find interesting professional opportunities!

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