Clinical Evaluation Expert

This job has now expired please search on the home page to find live IT Jobs.

Clinical Evaluation Expert

We are looking for you as our new Clinical Evaluation Expert. In this project you will be directly involved in the change management process of a leading medical device company in Switzerland. The area of responsibility includes the conduction of a gap analysis according to the new European Medical Device Regulations (MDR), especially ensuring that Clinical Evaluation plans and reports are reviewed and compliant with changing regulations. You are a structured, ambitious and goal-oriented person who wants to make important strategic decisions and contribute to the company´s success.

Main tasks:

* Set up Clinical Evaluation Plans (EVP) and reports according to the new Medical Device Regulation (MDR)

* Review existing Clinical Evaluation Documents

* Development of Post-Market Clinical Follow-up (PMCF) strategies according to the new Medical Device Regulation (MDR)

* Updating relevant Standard Operating Procedures (SOP)

* Set up action plan for Post-Market Surveillance (PMS)

* Close cooperation with other internal departments, throughout the Clinical Evaluation Process of medical devices

Your profile:

* PhD in a Bio-Scientific or Medical discipline

* Experience in a similar position, in the Medical Device or Pharma industry

* Minimum 7 years' experience in Medical writing, with Regulatory Affairs or clinical evaluation background

* Writing clinical evaluation plans and reports according to the MEDDEV 2.7.1 guideline

* Reviewing input for the Clinical Evaluation Report (technical file documents, marketing claims, post-market surveillance data)

* Knowledge of ISO 13485, ISO 14971 & European Device Regulations (MDR)

* Excellent written and verbal communication skills in German and English

* Excellent knowledge of MS Office applications

* Structured, ambitious and goal-oriented personality

Key facts:

Start Date: January/February 2018 Length: minimum 10 months

Extension: possible

Location: Central Switzerland

Workload: 100%

Sounds interesting? Those are the next steps:

If the position sounds interesting, please contact us and send us your updated CV.

If you have any questions, please do not hesitate to contact me any time. Looking forward to working with you.

Best regards

Elena Reeb

Recruitment Consultant Medical Devices

T: +41 (0) 44 588 2619

E: e.reeb(at)realstaffing.com

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.