Beschreibung
6 months contract - Study director - biocompatibility- medical devicesAn exciting temporary opportunity has become available for an experienced Project Manager in the area of biocompatibility for medical devices products.
In this role, you will be responsible for planning , coordinating and implementing 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.
POSITION DUTIES & RESPONSIBILITIES:
* Evaluating the required material and influencing the product quality, particularly in the area of biocompatibility.
* coordination and interpretation of product testing in internal and external laboratories in the field biocompatibility and chemical analyses
* Review laboratory data for accuracy, consistency and completeness; identify results with potential issues requiring further investigation
* Interpret spectra, chromatograms and microscopic
- Creating Reports and Rationales
* Collaboration with external consultants (risk analysis and toxicological evaluations) globally
* Working in a global team and collaboration with colleagues in the field of biocompatibility.
* Updating, maintenance or rebuilding of work instructions and other for Quality relevant documents in the document management systems.
PROFESSIONAL EXPERIENCE REQUIREMENTS: - Education to a life science or engineering degree
- already gained experience in European Medical device industry especially with regulatory, quality settings
- Knowledge of the standard family ISO
- Experience in Good Manufacturing Practice (GMP)
- Background in process and cleaning validation
Michael Bailey International is acting as an Employment Business in relation to this vacancy.