Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Regulatory Affairs Specialist

Eingestellt von Experis AG

Gesuchte Skills: Engineering, Client

Projektbeschreibung

REGULATORY AFFAIRS SPECIALIST - ZUCHWIL (NEAR SOLOTHURN) - 100%

Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.

For our international client based in Zuchwil, Experis is currently looking for a Regulatory Affairs Specialist for a contracting position until, at least, the end of 2018.

General information:

- Start date: ASAP
- End date: 31.12.2018
- Work location: Zuchwil
- Workload: 100%

Tasksassist in review of international product technical documents, marketing and labeling materials
- Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
- Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
- Providing progress of work-plans and the status of key project deliverables
- Follow the quality standards and regulatory requirements

You bring for this role the following qualifications:

- 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering
- Strong knowledge of ISO 13485 and ISO 9001, QSR Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745
- Reasonable knowledge of FDA requirements registration
- Strong understanding of Risk Management process, label and labeling, change management is desired
- International experience preferred
- Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
- Strong knowledge and skills in MS Office
- Familiarity with Technical Documentation structure according to STED required
- English spoken and written (German would be a plus)

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Stéphanie Vogt.

Projektdetails

  • Einsatzort:

    Zuchwil, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Experis AG