Regulatory Affairs Coordinator

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

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, theFreedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debtprogramandFreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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.

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,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

The base pay for this position is $24.65 – $49.35 per hour. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]