Regulatory Affairs Coordinator

Abbott Regulatory Affairs CoordinatorAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with high employer contribution.Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.The OpportunityAs a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.This Regulatory Affairs Coordinator will work on-site at our Sylmar, CA location in the Cardiac Rhythm Management Division. This new team member will provide administrative support for regulatory processes and procedures. The individual may coordinate and support technical and scientific regulatory activities, research regulations and guidance, and organize and maintain key information sources.What You'll Work OnResponsible for compliance with applicable Corporate and Divisional Policies and procedures.Strategic Planning:Execute global regulatory assessmentAnalyze, plan, execute and track Product Release AuthorizationsDevelop, analyze and execute on improvements to regulatory processesCollaborate cross functionally for inputs to regulatory processesSOP and other document maintenanceMaintain records on legislation, regulations and guidelinesAssist in monitoring and reporting project timelinesPremarket:Secure global regulatory assessments for input into global regulatory strategyAssist in the releasing of product to marketAssist in the compilation and organization of materials for presubmission reportsAssist in the preparation of submission/registration packagesAssist in the organization of materials from preclinical and clinical studies for reviewAssist in notarization of documentsPostmarket :Update and maintain paper/electronic document regulatory files and archival systemsAssist in the preparation of routine reports and regulatory agency communicationsAssist with internal audits and inspectionsAssist in the preparation of postmarket reports and submissionsUpdate and maintain global product listings, facility registrations, licenses/approvals, and annual registrations.Required QualificationsTechnical Diploma (± 12 years)Minimum 1 year related experiencePreferred QualificationsAssociate's or Bachelor's degree in a technical area (such as biology, chemistry, engineering, microbiology, immunology, medical technology, pharmacy)Experience in a regulated business environment (e.g., legal office, regulated industry).Project Management skillsExperience with Windchill or other PLM systemThe base pay for this position is $24.65 – $49.35 per hour. In specific locations, the pay range may vary from the range posted.