A BDN client located in New Jersey is looking for a toxicologist who can provide at least six months of consulting coverage. This position will task the contractor with conducting a review of all existing files for a risk assessment as it relates to the EU MRB process. If testing is required, then the consultant will be responsible for rewriting the assessment. Risk assessments to be completed will need to be compliant with ISO 10993 in order for FDA submission to be completed. On the job, the consultant can expect to work with product development, manufacturing, lab personnel as needed based on the findings of the risk assessment.
8 plus years of experience.
Working knowledge of international medical device regulations.