Regulatory Affairs Specialist (f/m/d)
12.06.2019 | Employee | 100%

The Regulatory Affairs Specialist is supporting the local RA team with the upkeep of RA standards as well as the submissions for new products.

Regulatory Affairs Specialist (f/m/d)

Our Client is an innovative global Medical Device company, located in the heart of Switzerland.

Description

  • Preparation of technical Submission files in relevant countries
  • Ensuring compliance with IVD- Directive, ISO 13485 and MDSAP
  • Participation in Field Corrective Actions
  • Preparation and Participation of internal and external Audits
  • Regulatory Assessment of all labels and additional printed items
  • Participation and coordination for the implementation of Corrective Actions
  • Evaluation of changes in regulation and the impact on marketed products
  • Preparation and management of Risk Assessments

Profile

  • Degree in a technical or scientific area
  • 2 - 5 years of experience as Regulatory Affairs professional
  • Knowledge of the current IVD Regulations and experience with their application and implementation
  • Experience with the registration of IVDs in the Swiss market
  • Strong knowledge of ISO 13485, European Directive 98/79/EC, IVR 2017/746, CFR 21 part 820
  • Fluent in English and German - French is a plus

Job Offer

- opportunity to work with a market leader in an international environment

- personal and professional development options (incl. professional training)

- competitive salary package

12.06.2019
Employee, 100%

Contact

Michael Page Switzerland
Quai de la Poste 12 1204 Geneva
1003 Bern
Michael Page
Quai de la Poste 12
Genève

Industry

Human resources / Personnel services
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