Regulatory Affairs Coordinator

Job Description 

About Abbott 

Abbott 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. 

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’ll also 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 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 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. 

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 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, analyze and execute on improvements to regulatory processes 

• Collaborate cross functionally for inputs to regulatory processes 

• SOP and other document maintenance 

• Maintain records on legislation, regulations and guidelines 

• Assist in monitoring and reporting project timelines 

Premarket: 

• Secure global regulatory assessments for input into global regulatory strategy 

• Assist in the releasing of product to market 

• Assist in the compilation and organization of materials for presubmission reports 

• Assist in the preparation of submission/registration packages 

• Assist in the organization of materials from preclinical and clinical studies for review 

• Assist in notarization of documents 

Postmarket: 

• Update and maintain paper/electronic document regulatory files and archival systems 

• Assist in the preparation of routine reports and regulatory agency communications 

• Assist with internal audits and inspections 

• Assist in the preparation of postmarket reports and submissions 

• Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations. 

Required Qualifications 

• Technical Diploma (± 12 years)  

• 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, pharmacy) 

• Experience in a regulated business environment (e.g., legal office, regulated industry). 

• Project Management skills 

• Experience with Windchill or other PLM system