Hays

Expert Biocompatibility Assessment (m/f/d)

Bensheim | Employment with Hays Professional Solutions GmbH
Reference number
512335/1
Start date
asap
My duties
  • Review of requirements of test systems and alignment with Research & Development, Quality & Regulatory and Production & Operations
  • Execute biocompatibility evaluations of marketed Bioregenerative and Implant Systems products according to current regulatory requirements
  • Execute tasks related to reprocessing topics, including cleaning and disinfection and process validation. Elaboration of statements for product documentation, regulatory approvals, IFUs and CAPAs of marketed Bioregenerative and Implant Systems products according to current regulatory requirements
  • Provide scientific and technical support related to biocompatibility issues for Development projects in cross-functional teams. 
  • Execute biocompatibility and cleanliness tasks for Bioregenerative, Implant Systems and Atlantis product platforms portfolios 
  • Elaboration of study plans, including timeline and costs. Support in prioritization of planned studies
  • Coordination of external service providers and academic partners such as institutes and test laboratories
  • Support in determination of biological, chemical and physical studies as well as assessment of study results. Monitoring of activities of external service providers
  • Perform research in scientific literature, standards- and internet databases
  • Computer-aided analysis of test results, preparation of specifications, reports and development documents
  • Use of internal software tools including SAP, PDM-Link and SmartSolve according to Quality Management of the company
My qualifications
  • Science orientated higher education with a biological background e.g. biology, chemistry or biotechnical sciences
  • Profound experience in medical device, pharmaceutical or equivalent industry
  • Knowledge of implants and other dental products, materials and methods of production
  • Knowledge of Medical Device Directive (MDD) and Medical Device Regulation (MDR)
  • Knowledge and experience in implementation of Quality Management Systems
  • Experienced in biocompatibility evaluation of medical devices
  • Research and Development relevant experience in the Medical Technology field, ideally the dental sector and a GMP environment
  • Profound knowledge of biological and chemical analytical methods
  • Experience in the evaluation of bioanalytical data and in the evaluation of Biocompatibility in accordance to ISO 10993 and EN ISO 7405
  • Excellent communications skills, very good knowledge of German and English
  • Knowledge of reprocessing- and cleanliness requirements of medical devices
  • Good command of software tools like MS Office, SAP, MS Project
My benefits
  • Cooperation in an international company
About Hays
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays

Reference number
512335/1

Contact
Phone: + 49 621 1788-4297
E-Mail: positionen@hays.de