Regulatory Operations Compliance Manager – Medical Devices

Abbott is a global healthcare leader offering life-changing technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. The Regulatory Operations Compliance Manager will be based on-site in Maple Grove or St. Paul, MN, and will manage projects related to harmonized regulatory activities in Abbott’s medical device division. This role combines knowledge of Regulatory, Quality, and Compliance to manage implementation projects for emerging regulations and lead quality compliance metrics for the Regulatory shared service organization. Responsibilities include leading procedural updates and emerging regulation implementation, developing new regulatory policies, processes and SOPs, facilitating procedure implementation, providing strategic input and technical guidance on regulatory requirements, evaluating regulatory risks, mentoring regulatory professionals, driving change order activities, creating supplemental training materials, reviewing document quality system structure, leading team meetings, collaborating with IT system enhancement teams, and authoring communications and presentations for upper management. Required qualifications include a Bachelor's Degree or equivalent experience, minimum 4 years in a regulated industry with 2-5 years in regulatory preferred, strong communication skills, and knowledge of domestic and international regulatory guidelines. Preferred qualifications include a science or technical degree, advanced degrees, certifications such as RAC, 5+ years experience, familiarity with regulatory affairs, CAPA experience, procedural writing, project management skills, and knowledge of regulatory history and standards.