Expert Medical Devices Safety and Performance

☞ gloor & lang Pharma and Biotech Recruiting

View: 153

Update day: 25-04-2024

Location: Lucerne Luzern LU

Category: Other

Industry: Staffing Recruiting

Position: Entry level

Job type: Full-time

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Job content

R&D - Medical Devices - Biocompatibility - ISO 10’993

Our client is a Swiss Medtech player, headquartered in the Bern. All tasks related to development, production and sales of medical devicdes are being carried out from the Swiss site.

Our client has an exceptionally large R&D department for innovative devices and continuously makes significant investments in state-of-the-art technology and equipment.

Your challenge
  • Define test strategies for the biological evaluation in relation to individual products, product families
  • Summarize test results that are carried out as part of the biological assessment
  • Create of biological evaluations according to ISO 10993 for Europe, USA and other countries
  • Ensure global compliance with legal requirements and compliance with standards and guidelines on the biological safety of products
  • Maintenance of the biological assessments for the approved products.
  • Create gap analyses of the ISO standard family 10993 ff and other relevant biocompatibility standards
  • Biocompatibility assessment for changes of approved products
  • Support and train project and product management teams as well as quality and regulatory teams on questions related to biocompatibility
  • Support teams in answering biocompatibility questions to regulatory authorities.
  • Maintenance and further development of the Ypsomed "Biological Evaluation" process.
  • Commissioning of external laboratories for chemical and biological analyzes according to ISO standard family 10993 ff
Your profile
  • BSc, M.Sc, PhD degree in life sciences/material sciences
  • Familiar with ISO 10’993 regulatory requirements for MD testing
  • Experience in evaluating the "Extractables" and "Leachables" studies
  • Experience in biocompatibility assessments for changes to authorized medical devices
  • Professional experience in a GMP-regulated
You have strong communication skills - both verbal and written, intellectual agility, and scientific interest. The existing structure of the team allows you to stand out in your field of competence and to influence significantly all future innovations.

Your English is excellent. You also speak German or you are ready to learn it. Then look forward to a pleasant and motivating workplace between city and the Swiss mountains.

Did we spark your interest? We are looking forward to receiving you complete applicationInterested? We are looking forward to get in touch with you.

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Deadline: 09-06-2024

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