Biocompatibility SME

Orange County, CA

Industry: Medical Device Job Number: 146990

Biocompatibility SME

Environment:

Our client is a large medical device manufacturer. They are in need of a consultant strong in Biocompatibility  SME for MDR compliance.

Duties/Responsibilities/Scope of Work

This individual will come from a Medical Device background, and must have strong, hands-on experience in  Biocompatability for Medical Device manufacturing, as well as Sterilization (Gamma/EBEAM/EO). This individual will be helping out with crucial projects related to multiple sites.  This project will be focusing on EU MDR regulations and determining compliance within their Biocompatability testing. This individual will be looking at full technical files and doing an initial gap assessment as well as the hands on testing.

This person must be comfortable with frequent travel throughout to US to manufacturing facilities that the business leans on, suppliers of the business, etc. Our client will lean on this person to perform sterilization and biocompatibility activities, properly document and record necessary data/information and report it back to them efficiently.  Specific responsibilities will include initiating  and completing Biocompatibility Evaluations, chemical characterization,  determining  which Biocompatibility Tests are required, sending out samples for testing, writing  Biocompatibility Protocols & Reports, etc. 

Required Experience:
  • Medical Device 
  • Biocompatability (Must have)
  • DHF

Plus:
  • Cardiovascular products or orthopedic products 

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