Regulatory Affairs Coordinator

About Abbott

Abbott is a leading global healthcare company committed to enhancing people's lives at every stage. We specialize in a broad range of life-changing health technologies, including diagnostics, medical devices, nutritionals, and branded generic medicines. Our workforce of 115,000 spans over 160 countries worldwide.

Working at Abbott

Joining Abbott means engaging in meaningful work that supports your personal and professional growth while providing comprehensive benefits. Employees enjoy career opportunities with an international leader, free medical coverage through our Health Investment Plan (HIP) PPO, a robust retirement savings program with strong employer contributions, tuition reimbursement and educational benefits such as the Freedom 2 Save student debt program and FreeU bachelor’s degree pathway. Abbott is recognized globally for its workplace culture, diversity, and inclusiveness for working parents, women leaders, and scientists.

Role Overview

We are seeking a Regulatory Affairs Coordinator to support regulatory activities within our Cardiac Rhythm Management Division at the Sylmar, CA facility. This role involves providing administrative and technical assistance to ensure adherence to corporate and divisional policies in regulatory processes.

Key Responsibilities

• Ensure compliance with corporate and divisional regulatory policies and procedures.
• Conduct global regulatory assessments and manage product release authorizations.
• Identify and implement process improvements to regulatory workflows.
• Collaborate cross-functionally to gather necessary regulatory inputs.
• Maintain SOPs, documentation, and records of legislation, regulations, and guidelines.
• Monitor project timelines and support reporting activities.
• Support premarket activities including organizing pre-submission materials, preparing registration packages, and assisting with document notarization.
• Manage postmarket documentation and regulatory files, facilitate communications with regulatory agencies, support audits and inspections, and update global product listings and facility registrations.

Qualifications

• Technical diploma equivalent to approximately 12 years of education.
• At least one year of relevant work experience.
• Preferred: Associate's or Bachelor's degree in biology, chemistry, engineering, microbiology, immunology, medical technology, pharmacy, or related technical field.
• Experience in regulated environments (e.g., legal or regulated industries) is advantageous.
• Project management capabilities.
• Familiarity with Windchill or other Product Lifecycle Management (PLM) systems is preferred.

Compensation

The hourly pay range for this position is between 24.65 and 49.35 USD. Actual salary may vary by location.