Regulatory Affairs Coordinator

Abbott is a global healthcare leader that creates breakthrough science to improve people's health. Position Overview This Regulatory Affairs Coordinator will work on-site at our Sylmar, CA location in the Cardiac Rhythm Management Division. The role involves providing administrative support for regulatory processes and procedures, coordinating technical and scientific regulatory activities, researching regulations and guidance, and organizing and maintaining key information sources. Responsibilities Ensure compliance with Corporate and Divisional Policies and Procedures. Execute global regulatory assessments, analyze, plan, and track product release authorizations and develop improvements to regulatory processes. Collaborate cross-functionally for inputs to regulatory processes and maintain SOPs and other documentation. Maintain records of relevant legislation, regulations, and guidelines. Assist in monitoring and reporting project timelines. Secure global regulatory assessments for pre‑market strategy and support product release to market. Compile and organize materials for pre‑submission reports and prepare submission/registration packages. Organize preclinical and clinical study materials for review and notarize required documents. Update and maintain paper/electronic regulatory files and archival systems. Prepare routine reports and regulatory agency communications. Assist with internal audits and inspections. Prepare post‑market reports and submissions. Update and maintain global product listings, facility registrations, licenses, approvals, and annual registrations. Required Qualifications Technical diploma (±12 years) and minimum 1 year related experience. Preferred Qualifications Associate’s or Bachelor’s degree in a technical area such as biology, chemistry, engineering, microbiology, immunology, medical technology, or pharmacy. Experience in a regulated business environment (e.g., legal office, regulated industry). Project management skills. Experience with Windchill or other PLM system. Compensation Base pay: $24.65 – $49.35 per hour. Benefits Free medical coverage through the Health Investment Plan (HIP) PPO. High employer contribution retirement savings plan. Tuition reimbursement. Freedom 2 Save student debt program. FreeU education benefit for obtaining a bachelor's degree. Job Details Job Family: Regulatory Operations Division: Cardiac Rhythm Management (CRM) Location: United States – Sylmar, CA 15900 Valley View Court Work Shift: Standard (8‑hour day) Travel: None Medical Surveillance: None Significant Work Activities: Continuous sitting for prolonged periods (>2 consecutive hours in an 8‑hour day), Keyboard use (≥50% of the workday) EEO Statement Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law (English): (Spanish): #J-18808-Ljbffr