ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. – $56,347.00/Year

Bachelors or foreign equivalent degree in BiomedicalMechanical Engineering, Medical Devices, PharmacyPharmacology, Regulatory AffairsSciences, or in a closely related technical field of study with at least 2 years of professional Regulatory Affairs experience. In addition, the position requires an academic or industrial background in i providing regulatory input and project management to product lifecycle planning, product testing protocols, reports, and product approval regulatory strategies; ii preparing regulatory submissions, maintain regulatory files for product registrations and product renewals, and ensuring regulatory compliance for medical devices pursuant to FDA 21 CFR Parts 801 820, GMP, ISO13485, and international regulatory requirements; iii maintaining EU technical files and design dossiers; iv assessing regulatory implications for product changes and determining trade issues to anticipate regulatory obstacles; and v providing regulatory support to crossfunctional project teams.