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Position Title: Regulatory Affairs Specialist
Location: Norwood, MA
Salary:
BACKGROUND CHECK AND DRUG TEST REQUIRED!
Completes the development of complex study protocols including risk rationales and/or advising the company on the appropriate study design. Works with the Quality department to ensure that appropriate levels of clinical and preclinical testings are completed prior to U.S. introduction. Works with the Quality department to ensure that proper local approvals are obtained and agreements are executed prior to installation. Performs and/or trains on the implementation and conduct of clinical and preclinical studies to assure data are collected in timely and cost effective manner and is consistent with regulatory standards. Completes the tracking of contracts/budgets for the studies. Completes clinical and preclinical regulatory submissions to support study data.
