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Regulatory Affairs Specialist - Medical Devices

Eingestellt von Experis AG

Gesuchte Skills: Engineering, Support

Projektbeschreibung

REGULATORY AFFAIRS SPECIALIST - MEDICAL DEVICES

Are you a highly qualified Regulatory Affairs Specialist with experience within a medical devices environment and looking for an exciting new opportunity with a market leading global company? If so, please have a look at the following details:

Experis IT Switzerland is currently on the search for a Regulatory Affairs Specialist to join one of their clients, a global and well renowned company specialized in medical devices based in Oberdorf.

For this temporary assignment we are in search of an English speaking candidate and ideally an intermediate level of German and who is available on a short notice period.

If yes we may have the right job for you!

YOUR RESPONSIBILITIES:

- Make sure that the medical devices are compliant with the product development process and with the applicable regulatory requirements (eg MDD 93/42/EEC)
- Organization and administration of technical documentation
- Update the technical documentation regarding current and new regulatory requirements and make sure that the documentation is conform with the EU and country specific requirements
- Evaluation of medical devices regarding their risk potential (based on EN ISO 14971)
- Support international releases of medical devices
- Prepare and support audits etc.

TO DELIVER THE BEST OUTPUT, IT'S NEEDED THAT YOU HAVE:

- MINIMUM 1-3 YEARS' EXPERIENCE IN REGULATORY AFFAIRS (MDD 93/42/ECC) of MEDICAL DEVICES with focus on CLASS I, IIA AND IIB
- Experience in US REGULATORY AFFAIRS
- A SCIENTIFIC, MEDICAL OR ENGINEERING BACKGROUND
- Good ability to work under pressure
- Great team player
- Fluent level of English
- German skills will be highly preferred

If you are a dynamic and solution-oriented Regulatory Affairs Specialist currently looking for a challenging new position that applies to your skills, then we look forward to receiving your application!

I'm always looking for skilled regulatory affairs specialist so please don't hesitate to send me your CV.

Don't hesitate and send us your CV today through the link in the advert. In case of any questions please contact Florence Wespiser. Please only apply if you have an EU or Swiss nationality.

Experis IT is Europe's leading IT&T recruitment agency.

Projektdetails

  • Einsatzort:

    Oberdorf (BL), Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Experis AG