Job Detail

Clinical Evaluation Specialist (m/f/x)

Inseriert am: 06.03.2019

Company Description


We are Straumann.
United for global excellence in dentistry.


Every vision has its story. Ours began more than 60 years ago. Since then our innovations and achievements have become landmarks in dentistry worldwide. Straumann began as a family-owned institute, grew into a publicly owned holding, and today comprises a number of international companies around the world.


The Straumann Group develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics and biomaterials for use in tooth replacement and restoration solutions or to prevent tooth loss.


Job Description


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.


 


YOUR TASKS



  • 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


Qualifications



  • 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


Additional Information


INTERESTED?


We offer:



  • Become part of a creative, inspired and engaged team and project on a mission: #WeRockDentistry

  • Bring your ideas to life – create your footprint in the dental industry

  • You can expect an informal, hand-on working environment with opportunities to grow


Florian Rupp, is your first contact for further questions you might have. Please apply via our online application system.


For this position, we are not asking for profiles of HR Consultancies and Recruiting Agents. Please respect this.


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