Clinical Evaluation Specialist (m/f)
17. Dec 2017
Place of work
Basel - Switzerland
Research + Development
Professionals (experienced, specialists)
We are looking for you as our new Clinical Evaluation Specialist (m/f), part of our Clinical Operations Team.
In this role you will be involved in the overall continuous improvement activities including document and process gap analysis, ensuring compliance with changing regulations, maintaining and updating of relevant SOP’s, templates, documents and archives. With your excellent communication skills, your systematic, structured, efficient and goal-oriented working style you will be part of our company’s success story. The position is based at our Headquater in Basel, Switzerland and reports to the Clinical Evaluation Manager.
- Writing of Clinical Evaluation Plans and Reports according to current European Medical Device Regulations
- Reviewing, structuring and revising existing Medical Device Clinical Evaluation Documents (Life Cycle Management)
- Systematic literature searches in appropriate data bases and documentation
- Proactive cooperation with Product Management and Development and other internal departments within the company to ensure smooth clinical evaluation process of medical devices
- Developing and reviewing Post Market Clinical Follow-up (PMCF) strategies
- Participating in Risk Management assessments and Post market surveillance (PMS)
- Enforce compliance to regulations and internal processes to adhere to the new Medical Device Regulations (MDR) standards
- Transferring of knowledge on Medical Device Regulations standards documentation into organization
- PhD in a Bio-Scientific or Medical discipline (e.g. Biochemistry, Biomedical Degree, Dentistry Degree), incl. professional experience in systematic literature searching
- About 3 years of experience in a similar position in a professional environment
- Excellent written and verbal communication skills in English
- Excellent command of MS Office applications
- Previous experience in Medical device or Dental industry
- Previous experience in Medical writing with RA or clinical evaluation background
- You are a communicative, very dynamic and agile team player as well as a structured and goal-oriented person
Florian Rupp, HR Partner, is your first contact for further questions you might have.
Please apply via our online application system or send your application via E-Mail to email@example.com.
For this position, we are not asking for profiles of HR Consultancies and Recruiting Agents. Please respect this.
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