Regulatory Affairs Coordinator

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.We’realways looking towards the future,anticipatingchanges in medical science and technology.

Working at Abbott

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’llalso have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for 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 debtprogramand_FreeU_education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized asa great placeto 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 Opportunity

As 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.

ThisRegulatory 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, researchregulationsand guidance, and organize andmaintainkey information sources.

What You’llWork On

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Strategic Planning:

• Execute global regulatory assessment
• Analyze, plan, execute and track Product Release Authorizations
• Develop,analyzeand execute on improvements to regulatory processes
• Collaborate cross functionally for inputs to regulatory processes
• SOP and other document maintenance
• Maintain records on legislation,regulationsand guidelines
• Assistin monitoring and reporting project timelines

Premarket:

• Secure global regulatory assessments for input into global regulatory strategy
• Assistin the releasing of product to market
• Assistin the compilation and organization of materials forpresubmissionreports
• Assistin the preparation of submission/registration packages
• Assistin the organization of materials from preclinical and clinical studies for review
• Assistin notarization of documents

Postmarket:

• Update andmaintainpaper/electronic document regulatory files and archival systems
• Assistin the preparation of routine reports and regulatory agency communications
• Assistwith internal audits and inspections
• Assistin the preparation ofpostmarketreports and submissions
• Update andmaintainglobal product listings, facility registrations, licenses/approvals, and annual registrations.

Required Qualifications

• Technical Diploma (± 12 years)
• Minimum1 yearrelated experience

Preferred Qualifications

• Associate's or Bachelor'sdegree 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 skills
• Experience with Windchill or other PLM system