An employer is looking for a REMOTE Biocompatibility Specialist to join the team for a 6 month EU MDR Remediation project. They will be responsible for meeting timelines of Biocompatibility deliverables to project teams. They will focus on MDR submissions and will be under directive for focus on biocompatibility as the MDR wants more evidence. The remediation process is expected to close in Early March. Review material and analytical data to support biological evaluation. Perform risk assessment of manufacturing process and materials. Create technical documents to aid biological evaluation of medical devices including BERs. Generate equivalency documents based on risk assessment and/or toxicological analysis of manufacturing process/processing aids. Ensure compliance with the client's and internal training, Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant guidelines.
- Degree in chemistry, analytical chemistry or materials science, toxicology
- 3-5 years of experience
- ** Strong technical knowledge of biocompatibility and understanding of material physical sciences and chemical/Chemistry properties
- Strong understanding of the manufacturing risks/process, working knowledge of chemical characterization (E/L studies) per ISO 10993-18 and 17 (preferred)
- Working knowledge of global regulations and requirements, especially the EU Medical Device Regulations (MDR).
- Must be based on West coast (highly preferred) or Central time zone
- Advanced Office Skills: Excel, Word, PPT
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.