Regulatory Affairs Coordinator (on-site)
AbbottAbout the role
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.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- 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 and product release authorization process
- 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
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
- High school diploma required
- Communicate effectively verbally and in writing
- Work with departmental teams
- Understand business and regulatory ethical standards
- Review documentation
- Learn to write technical documents
- Meet deadlines
- Pay strong attention to detail
- Research and locate information on regulatory requirements and products
- Learn to use professional concepts and company policies and procedures to solve routine problems
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).
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds. Free account required — sign up in 30sApply for this role