Open-ended / Ad-hoc
Our Medical Device client is currently seeking a Biocompatibility Specialist for a compression wrap that classifies as a 510k Class II Medical Device. The biocompatibility specialist would come into the project to assist with issues on mainly one portion of the product that they are having an unidentified deficiency with part of the wrap making an appropriate level of contact. The company lacks in-house expertise so it is imperative that candidates considered for this position have a proven track record of working on biocompatibility / toxicity for relative Class II medical devices as the client will truly be leaning on the consultant for guidance on problematic errors, corrective actions, etc.
Experience with class II medical devices, ISO 10993, and a working history of providing guidance/advise on biocompatibility and toxicity issues is required for consideration. Familiarity with products similar to DonJoy Iceman Cold Therapy or Polar Cube Water Circulating Pads is highly preferred.
Remote: Biocompatibility Specialist (233784)