Role: Technical Assistant - Biocompatibility / Medical Devices Product Safety
Location: Leeds
Salary: Highly Competitive
Our client is looking for a new addiction to their New Product Development Team. You will have experience within Medical Devices and Bio-Compatibility. This is an excellent opportunity to join a family run growing business within West Yorkshire. You will also have a background within NPD and Medical Device Product Safety.
Role:
- Preparing biocompatibility plans and reports for new and existing products to ensure compliance with ISO 10993 and changing regulatory requirements
- Following a risk-based approach, determine the testing required and liaise with the relevant test houses to ensure this is carried out accurately and in a timely manner.
- Support the R&D Department during the design and development of a product by providing technical guidance on biocompatibility requirements.
- Assessing the impact of changes to existing products and processes on the biological safety of a device.
- Additional duties may include carrying out shelf-life studies, including packaging and product stability.
- Updating PFMEA files.
Person:
- A good understanding of biocompatibility issues
- A skilled technical writer.
- Previous experience in medical device product safety.
- Degree within Biology / Microbiology / Chemistry
