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 109,000 colleagues serve people in more than 160 countries.

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

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Labeling Specialist II is within our Toxicology business unit located in Pomona or San Diego. In this role, you will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for domestic and international product registrations for new and modified products, regulatory assessment of product changes, review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files.

WHAT YOU WILL 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
• Applies US, EU, and international regulations and standards on IVD and MD product labeling to assure compliance with quality and regulatory requirements.
• Manages labeling translations to support country registrations
• Ensures labeling artwork to meet all medical, legal and regulatory requirements
• Provides labeling regulatory support for diagnostic product development and commercial diagnostic products
• Supports to maintain approvals/licenses/authorizations for existing marketing authorizations
• Adds and maintains labeling information contained in the Global Regulatory Information Database, as needed
• Supports development of of internal procedures and tools
• Conducts informational or training sessions for stakeholders, as needed
• Organizes and maintains hard copy and electronic department files, as needed
• Keeps informed of global regulatory information
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Company 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 company’s policies and practices.
• 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.
• Perform other duties & projects as assigned.

MINIMUM REQUIREMENTS:

• Bachelor's degree (BS/BA) in any scientific field
• 2-3 years’ experience in Regulatory Affairs
• Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor
• Must be detail-orientated, self-motivated and available for flexible scheduling
• Strong communication, problem solving and motivational skills
• Demonstrated written and verbal communication skills

PREFERRED EXPERIENCE:

• One to three years in an IVD or medical device manufacturing environment
• Good knowledge of federal regulations
• Good knowledge of product labeling and related requirements
• Good knowledge of quality systems in a regulated manufacturing environment

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, incentives 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.

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