Job Description

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 107,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION:

About Abbott

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbotts life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics

Our location in Pomona, CA or San Diego, CA currently has an opportunity for a Regulatory Affairs Specialist I - Labeling. This role will work as part of the Regulatory Affairs department with direct support of the labeling creation and approval process within the Post Market Sustaining group. In this position, you will create direct product labeling using specialized software and Microsoft Office applications, routes labeling in the change management system, and interfaces with Engineering and vendors to obtain and approve labeling proofs.

WHAT YOULL DO
\- Creates and/or revises direct product labeling according to the requirements in domestic and international standards and regulations
\- Interfaces with Engineering and Process Improvement departments to determine label specifications and obtain labeling proofs
\- Interfaces with Marketing and Commercial teams to support customer and private label initiatives
\- Interfaces with vendors and external graphic designers to obtain and approve artwork files and proofs
\- Assists with review of advertising and promotional labeling to ensure compliance with product claims
\- Participates in product development projects and post-market projects as extended team member specializing in labeling
\- Organizes and maintains hard copy and electronic department files, as needed
\- Adds and maintains labeling information contained in Regulatory Registration Lists and the Global Regulatory Information Database, as needed
\- Assists in the maintenance of Labeling standard operating procedures, desktop instructions, templates and forms
\- Carries out duties in compliance with established business policies
\- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies
\- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices
\- Performs other duties and projects as assigned
\- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

EDUCATION AND EXPERIENCE YOULL BRING

Required

\- Bachelors degree (BS/BA) in a scientific or technical discipline or equivalent experience
\- One or more years of experience in Regulatory Affairs

Preferred
\- One to two years in an IVD or medical device manufacturing environment
\- Introductory knowledge of federal and international regulations
\- Introductory knowledge of quality systems in a regulated manufacturing environment
\- Good knowledge of product labeling and related requirements
\- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
\- Proficient with graphics design software
\- Demonstrated written and verbal communication skills
\- Ability to work on multiple projects simultaneously
\- Possess a high degree of accuracy and attention to detail
\- Ability to work independently, as well as within a team

COMPETENCIES:
\- Driven for results
\- Teamwork
\- Communication
WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

* Training and career development, with onboarding programs for new employees and tuition assistance
* Financial security through competitive compensation and retirement plans
* Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
* Paid time off
* 401(k) retirement savings with a generous company match
* The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

JOB FAMILY:

Regulatory Operations

DIVISION:

ARDx Abbott Rapid Diagnostics

LOCATION:

United States > Pomona : 829 Towne Center Drive

ADDITIONAL LOCATIONS:

United States > San Diego : 9940 Mesa Rim Road

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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