Study Director Biocompatibility
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 email@example.com, quoting job ref 48370.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.