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Regulatory Operations Compliance Manager – Medical Devices (on-site)

Abbott
Est. $96,461 - $230,000 / year
Posted Jun 30
Full Time
On Site
Minneapolis–Saint Paul, Wisconsin

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Regulatory Operations Compliance Manager will join the team on-site in Maple Grove or St. Paul, MN. This role is under Global Regulatory Services managing projects related to harmonized regulatory activities in Abbott’s medical device division. The Compliance Manager 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 with cross-functional teams, 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 quality system maintenance activities. The position involves standard work shift with 5% travel and some physical activities such as prolonged sitting and repetitive arm movements.