Biocompatibility Study Director

For a short-term project with our client in Baselland, we are looking immediately for a Biocompatibility Study Director.

Tasks:

- Compile documentation for medical devices in respect to cleanliness and biocompatibility
- Prepare the complete and traceable electronic documentation of the Biological Safety Evaluation (part of the Device Master Record (DMR)
-Assess the cleanliness and biocompatibility status of existing manufacturing processes (with support of further subject matter experts)
- Coordination of external laboratory cleanliness testing, review of externally and internally generated reports and writing summary reports
- Interface between different functions (manufacturing, process validation, material testing, risk management)

Further qualifications:
- Knowledge of the standard family ISO 10993-1 is an advantage
- Proven analytical skills, independent, versatile, and energetic work style
- Excellent organizational skills
- Experience in Good Manufacturing Practice (GMP)
- Background in process and cleanliness validation
- Proficient with MS Office Tools (Word, Excel)

Non-Technical profile requirements:

- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow change management for internal guidelines.
- Language proficiencies: English and German spoken and written