Study Director Biocompatibility

  • Salary: 90-100 CHF per hour
  • REF Number: 00048370
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 12.06.2020
  • Sector: Medical Devices
  • Location: Central Switzerland
  • Discipline: Science - Microbiology

CK QLS are recruiting for a Study Director Biocompatibility to join a company leading medical device company at their site based in Oberdorf on contract basis for 6 months, with the possibility of extension.

Study Director Biocompatibility Role:The main purpose of the role will be to:

  • Plan, coordinate and implement of all activities for Biological Safety Evaluation of Medical Devices according ISO 10993 and maintain compliance in accordance with the new EU Medical Device Regulations.
  • Evaluate the required material and influencing the product quality, particularly in the area of biocompatibility.
  • Assign, co-ordinate and interpret product testing in internal and external laboratories in the field biocompatibility and chemical analyses.

Further responsibilities will include:

  • Reviewing laboratory data for accuracy, consistency and completeness; identifying results with potential issues requiring further investigation.
  • Creating Reports and Rationales.
  • Updating, maintenance or rebuilding of work instructions and other for Quality relevant documents in the document management systems.

Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Previous experience in European Medical device industry especially with Regulatory, Quality or Engineering.
  • Master's (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
  • Knowledge of ISO 10993-1 is an advantage.
  • Experience in Good Manufacturing Practice (GMP).
  • Background in process and cleanliness validation.
  • German skills would be a strong asset.

The Benefits: This is an excellent opportunity to join a leading medical device company.

Apply: For more information or to apply for this Study Director Biocompatibility position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email, quoting job ref 48370.

Please could you send any correspondence in English.

It is essential that applicants hold entitlement to work in Switzerland.

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