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Job Information

Abbott Regulatory Labeling Specialist I in Plymouth, Minnesota

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 113,000 colleagues serve people in more than 160 countries.

Regulatory Affairs Labeling Specialist

Plymouth, MN

The Regulatory Labeling Specialist I is responsible for the development of medical device labeling for the Cardiovascular Division by coordinating across functions as well as multiple US and international groups

Responsibilities:

  • Creates and modifies labeling for product labels, cartons and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines and branding guidelines.

  • Supports a cross-functional team collecting labeling content and translating it into functional label layouts utilizing labeling software. Mostly works on commercialized product labels.

  • Works with other functions to identify and resolve labeling inconsistencies with labeling material and requirements and to meet project objectives.

  • Creates and manages labeling change requests within the document management system.

  • Designs product labeling considering such factors as product identification, worldwide requirements, sales appeal, aesthetic quality, printing and production techniques.

  • Schedule/deadline provided for assigned work/tasks.

  • Maintains knowledge of new developments in packaging and labeling technologies.

  • Manages multiple concurrent deadlines.

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

  • Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications (Must be evident on resume):

  • Bachelor’s degree (Science, Biology, Regulatory, Mechanical Engineering, Biomedical Engineering or related majors preferred)

  • Experience working within a team and as an individual contributor in a fast-paced, changing environment

  • Ability to travel 5% including possibly international travel

Preferred Qualifications:

  • Experience working with product labeling, design dossiers, quality systems and/or regulatory labeling

  • Experience developing artwork and graphics for FDA regulated medical products and creation and management of change requests in an electronic environment

  • Experience utilizing computer-aided design equipment and/or graphic tools such as, CAD, Adobe Illustrator/Photoshop and other related software

  • Ability to schedule and organize multiple projects

  • Ability to communicate effectively with internal and external customers and team members.

  • Thorough knowledge of FDA, GMP, and ISO guidelines

  • Requires ability to be innovative, resourceful, and work with minimal direction

  • Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams

  • 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.

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

  • Student Loan Repayment 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: _ www.abbottbenefits.com (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.

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 corpjat@abbott.com

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