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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 114,000 colleagues serve people in more than 160 countries.

Job Description

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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (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 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

The **Labeling Specialist II** position works out of our Sylmar, CA location in the **Cardiac Rhythm Management** Division. 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.

**Labeling Specialist** designs, creates, updates, and maintains labeling text, graphics, and specifications for new and existing medical device products. Coordinates with Engineering, Marketing, Clinical Research, and Regulatory Affairs to define product labeling requirements. Designs and updates labels/labeling to ensure accuracy, visual appeal, cost efficiency, and compliance with applicable regulations, industry standards, and company requirements.

What You'll Work On

This position:

+ Gathers input for labels and IFUs from Engineering (Manufacturing, Packaging, etc.), Marketing, Clinical Research, and Regulatory Affairs (RA) to define specific requirements for product labeling by attending project meetings and meeting with or talking to individual content experts as necessary.

+ Works with Engineering and RA to establish and maintain accurate marketing and geographical labeling build configurations by reviewing Marketing requirements and launch plans and RA filing strategies.

+ Enhances professional appearance and legibility of Instructions for Use (IFU) by editing for grammar, consistency, style, and format.

+ Assists with Regulatory submissions and filings by providing the relevant labeling samples and change information.

+ Coordinates final labeling implementation to ensure that all requirements and deadlines are met by working with contract graphic designers, Abbott Vascular packaging experts, and print vendors.

+ Produces labeling artwork by defining artwork requirements, designing formats using departmental computer graphics software (e.g., Adobe Photoshop, Adobe Illustrator, Adobe InDesign, MS Word, and EasyLabel), Label Vision Inspection System, or working with contract graphic designers, and creating artwork packages.. Prepares Change Orders (COs) and specifications for approval by writing CO and specifications for CO originator to obtain approvals.

+ Maintains labeling history files and old versions of labels and IFUs by retaining samples of and documentation for the most current versions of artwork and archiving samples or electronic copies of previous labeling.

+ Maintains internal procedures for labeling design, processing, and control to ensure compliance to legal requirements by regularly reviewing and updating the procedures as necessary.

+ Monitors, evaluates, and recommends improvements to labeling processes, quality, systems, tools, and policies by staying informed of new technology, standards, regulations, and company and departmental initiatives.

+ Establishes and cultivates an extensive network of support to facilitate completion of assignments.

+ Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. May lead a project team.

+ Participates in determining goals and objectives for projects.

+ Influences middle management on technical or business solutions.

+ Interacts with vendors on print processes.

+ May attend press checks, representing Abbott Vascular and approving print quality and production run on behalf of the company.

+ Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and is cognizant of customers and time zones outside of the US. Establishes priorities of work assignments.

+ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.

Required Qualifications

+ Bachelors Degree Related field Or an equivalent combination of education and work experience

+ Minimum 3 years

+ Proven ability to learn new software applications quickly.

+ Experience in Product Data Management (PDM), Manufacturing Execution System (MES), Enterprise Resource Planning (ERP), or SAP systems preferred..

+ Prefer experience in Medical Device and/or a regulated environment.

+ Very strong MS Excel skills and experience with other MS Office Software (MS Word, PowerPoint, MS Project)

+ Exceptional organizational skills.

+ Ability to work in a highly matrixed and geographically diverse business environment.

+ Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.

+ Strong organizational and follow-up skills, as well as attention to detail. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.

+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

+ Ability to travel approximately 5%, including internationally.

**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.

The base pay for this position is $79,500.00 – $138,700.00. 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]