Regulatory Affairs Specialist

  • Salary: Competitive
  • REF Number: 00035053
  • Consultant: Mary Tilston
  • Contact: 01438 768717
  • Date Published: 08.02.2016
  • Closed Date: 12.05.2016
  • Sector: Medical Devices
  • Location:
  • Discipline: Regulatory Affairs

Mary Tilston is recruiting for a Regulatory Affairs Specialist to join a company in the pharmaceutical industry at their site based in Switzerland on a short-term contract basis.

The main purpose of the role will be to:

  • Support the internal Regulatory Affairs group in creating and maintaining Technical File documentation.
  • Write technical File summary reports
  • Create and maintain Technical files in the Product Lifecycle Management system.

Further responsibilities will include:

  • Review Technical File documents such as Clinical Evaluation Reports, Risk management Files and Standard Evaluations with respect to regulatory requirements.
  • Review labelling and promotional material for accuracy and consistency.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Educated to degree level or above in life sciences or a related field with considerable experience within the European Medical Device industry particularly in regulatory, labelling, quality or engineering.
  • Profound knowledge of EU Medical Device regulations, especially Council Directive 93/42/EEC and experience of creating and maintaining Technical Files according to the STED structure.
  • Strong IT skills including Microsoft applications, database skills and PLM Agile and SAP software.
  • Fluency in both English and German (written and spoken) would be beneficial.

This is an excellent opportunity to join one of the leading global pharmaceutical companies with great potential and opportunities to develop your career.

For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email mtilston@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL35053 in all correspondence.

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