34 days ago on proclinical.com

CE Specialist

ProClinical AG

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CE Specialist

ProClinical is seeking a CE Specialist for a world leading medical device company, this position will be based in Zurich on a permanent basis. This role in the Clinical Research department involves clinically evaluating the safety and performance of company products according to MEDDEV 2.7.1 in addition to conducting literature searches. It is also required to be a part of other design-control activities such as risk assessment and to contribute to Instructions for Use. The role plays a significant part in both the development of new products and the management of lifecycle projects. Another main aspect of this role is to manage investigator-initiated studies by following up on study progress with investigators and to provide the necessary support.

Job Responsibilities:

  • Writing clinical evaluation plans and reports according to the MEDDEV 2.7.1 guideline
  • Working cross-functionally with Product Development, Regulatory Affairs, Product Management, Launch Team and Marketing on pipeline projects
  • Managing investigator-initiated trials by handling incoming proposals and following up on approved projects
  • Managing statistical evaluation of study results within the clinical research department
  • Screening and identifying business and product relevant scientific literature
  • Analysing and interpreting study results and compiling literature search reports relevant for regulatory submissions

Skills and Requirements:

  • Diploma in a relevant scientific discipline or equivalent (MD, DMD), PhD is an advantage
  • Minimum of two years' experience of Clinical Evaluation Report writing in a medical device industry setting
  • Minimum of two years' experience in planning, executing, reporting and publishing clinical studies within a medical environment
  • In depth understanding of global clinical processes and clinical investigation design during product development for medical devices (ISO 14155)
  • Interpersonal skills and ability to work independently and within a team environment
  • Strong scientific understanding, ability to face complex problems and identify adequate solutions with a cross functional impact, knowledge of the dentistry sector is an advantage
  • Fluent in written and spoken English, any other language is an asset

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Valaince Penteng on +44 203 8460 643 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.