ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. – $109,200.00/Year

Masters or foreign equivalent degree in Regulatory AffairsScience, PharmacyPharmacology, Medical Technology, Biomedical Engineering, Biology, Chemistry, Microbiology, or in a closely related regulatory affairs or healthmedical sciences field with at least 2 years of experience in i monitoring and navigating evolving regulatory requirements for Class III medical device manufacturing, design, labeling, quality system changes, and regulatory submission strategies; ii executing preapproval compliance activities for FDA, EU and various regulatory agencies, including LetterToFile, Periodic Reports, Supplements, Technical Files, Design Dossiers, and Change Notifications, and maintenance of Device Registrations and Certificate Renewals; iii reviewing and approving advertising and promotional items to ensure regulatory compliance with post marketing approval requirements; iv providing audit support using knowledge of Quality System Regulation QSR 21 CFR 820, EU Medical Device Directive EU MDD 9342EEC, EU Medical Device Regulation EU MDR 2017745, Canadian Medical Device Regulation CMDR, Australia medical device regulations ARTG, Japan regulations and current ISO 13485 requirements; v communicating with regulatory agencies during submission review process; and vi working on multiple competing priorities and mentoring and training regulatory affairs professionals.