Regulatory Affairs Specialist 93/42/EEC Technical Documentation Access

Regulatory Affairs Specialist

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich. We are excited to help you in your search. We focus on finding the best contracts for the best contractors.

We are looking for a Regulatory Affairs Specialist for our client based in Zuchwil.

The responsibilities of this position include:

- Support the internal Regulatory Affairs team in creation and maintenance of Technical File documentation for EU Class I devices according to Council Directive 92/42/EEC:
- Creation of Technical File Summary Reports, Essential Requirements Checklists, List of Applied Standards
- Reviewing of and providing input for Clinical Evaluation Reports, Risk Management, Labeling.
- Providing Regulatory input and support for upcoming MDR revision-
- Creating and Maintaining of data sets that support Technical File maintenance and sustainability.

What we require from the candidate:
- Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
- 2-3 years of experience in European Medical device industry especially with regulatory, labeling, quality or engineering.
- Familiarity with Technical Documentation structure according to STED
- Technically versed in computer software such as MS Word, Excel, Powerpoint
- Strong database skills (Access) desired
- Strong analytical skills and network thinking
- English and German spoken and written

Whether this role is the right fit or you would like to see if there are others that do, our dedicated and expert team is looking forward to hearing from you.

Good to know you!