Description de l'offre
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Specialist I, Labeling to create and modify 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.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on Abbott:
- 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
Your experience(s), education and knowledge will further expand Abbott's marketplace success:
- Bachelor of Science degree in Engineering, Regulatory or technical field (minimum) and 1 – 4 years working in a labeling capacity
- Required 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
- 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%
- Ability to maintain regular and predictable attendance.
Your preferred qualifications and education:
- Experience in a regulated environment is preferred
- Experience utilizing Illustrator and labeling software (e.g., Easy Label, Nice Label or equivalent) is preferred
- Experience working in a broader enterprise/cross-division business unit model preferred
JOB FAMILY:Regulatory Operations
DIVISION:CAHF Cardiac Arrhythmias & Heart Failure
LOCATION:United States > Minnesota : 5050 Nathan Lane N.
TRAVEL:Yes, 10 % of the Time
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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