Expert-Biological Safety / Toxicology for Medical Devices

 knoell Germany GmbH  Mannheim, Mannheim
We have been an independent service provider for the agrochemical and industrial chemical industry since 1996, with currently over 570 employees at sites in Europe, Asia and the USA. As a leading service provider with an international focus, we offer comprehensive advice on the registration of agrochemicals, biocides, industrial chemicals, veterinary pharmaceuticals, medical devices and biotechnological pharmaceuticals.

You are searching for a position in a modern, professional, fast growing internationally active organization? You feel comfortable working with a high degree of responsibility and independence and look for the possibility to grow further in your job?
To support our globally recognized team of toxicologist, we are currently seeking an

       Expert - Biological Safety / Toxicology for Medical Devices
       - full-time or part-time with min. 32h on 5 days per week / permanent contract -

       Ref. No. 2019-01/JV

Activities and responsibilities

  • Biological evaluation of Medical devices in the framework of the Medical Device Regulation (MDR), ISO 10993-series and other relevant regulatory guidelines/requirements
  • Development of  biological evaluation strategies
  • Searching for relevant literature and evaluation of toxicological studies and publications for critical human health effects
  • Preparation of toxicological risk assessments for medical devices, based on the used raw materials, on extractable and leachable chemicals or on biocompatibility studies
  • Compilation of scientific expert statements
  • Acting as study monitor and sponsor representative for biocompatibility studies placed at contract laboratories
  • Assurance of high quality within projects (i.e. reports, expert statements, correspondence, quotations)
  • Communication and close co-operation  with other knoell expert teams
  • Client support in validation of sterilization processes and of packaging materials
  • Communication and close co-operation with our clients
  • Communication and interaction with authorities

Qualification profile

  • More than three years professional experience in regulatory toxicology and biological safety
  • University degree preferably in toxicology, biology or a related field
  • Board certification as toxicologist (ERT, DABT or equivalent) would be an asset
  • Detailed knowledge of risk assessment approaches and of in vivo and in vitro methods for safety / toxicology assessment
  • Excellent communication, presentation and organizational skills in a multinational environment
  • Proactive personality with the ability to work self-motivated
  • Service oriented personality and attitude
  • High personal responsibility with decision-making ability
  • Quick learner, able to react to new challenges
  • Very good language skills in English and German (spoken and  written); additional language skills would be an asset

Benefits

  • You will be working in a modern, professional, fast-growing, internationally active organisation with a high degree of responsibility and independence
  • Intensive on-the-job training will be provided in a competent multidisciplinary team
  • Detailed induction training course for new employees
  • Our knoell academy offers various training opportunities
  • We support the compatibility of work and family by offering flexible working hours as well as childcare subsidy
  • We offer the opportunity to participate in the company pension scheme
  • Under specific conditions you have the chance to participate in the employee participation program
Location   Mannheim or Leverkusen

Send application to

knoell Germany GmbH
Human Resources
Konrad-Zuse-Ring 25
D-68163 Mannheim

Contact:
Mrs. Nadja Seiler, phone +49 621 718858-136
Mrs. Isabelle Kästel, phone +49 621 718858-256

www.knoell.com

While applying for the job please refer to jobvector and use the following reference number: 2019-01/JV

About knoell Germany GmbH

Die knoell Germany GmbH  ist seit 1996 als unabhängiger Dienstleister mit nunmehr über 570 Mitarbeitern an Standorten in Europa, in Asien und in den USA aktiv. Als industrienaher Dienstleister mit internationaler Ausrichtung bieten wir umfassende Beratung in der Registrierung von Agrochemikalien, Bioziden, Industriechemikalien, Tierarzneimitteln, Medizinprodukten und biotechnologischen...

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