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:

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

The base pay for this position is

$24.65 – $49.35/hour
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

CRM Cardiac Rhythm Management:

LOCATION:

United States > Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

• EEO is the Law link

• English: http://webstorage.abbott.com/common/External/EEO_English.pdf

• EEO is the Law link

• Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf