Requires a Masters degree in Regulatory Affairs, Biomedical Engineering, or closely related field; and 2 years experience as a Regulatory Affairs Specialist or related occupation in Regulatory Affairs.br br Must possess at least 2 years experience with each of the followingbr br PreMarket Approval or 510k submissions for US Class III or Class II medical devicesbr MDD design dossiers, technical files and change notifications, or Design History Filesbr Total product lifecycle regulatory activities to include preclinical, clinical, approval, postapproval, and obsolescencebr 21 CFR Parts 11, 803, 806, 807, 814, 822, 830, and 860br QSR 21 CFR 820, EU MDD 9342EEC, CMDR, ISO 13485, and ISO 14971br br Multiple positions available.br This position is open to telecommuting from anywhere in the United States.

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