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RCommunicationCollaboration
About this role
Job Description Summary
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
A successful applicant for the Labeling Documentation Specialist position must possess documentation skills using Microsoft and Adobe software and must have excellent written and verbal communication skills. Must be organized and extremely detail-oriented and able to facilitate the approval of accurate and compliant product labeling.
The Labeling Documentation Specialist works in the Research and Development Department, under direct supervision facilitating and tracking the approval of labeling artwork for finished medical devices. This position includes the below responsibilities, as well as other duties in support of the approval of labeling in an Electronic Documentation Management System (EDMS).
RESPONSIBILITIES
Demonstrates knowledge of, and the ability to apply, labeling procedures and processes.
Accountable for the execution of specific tasks with oversight from a supervisor and/or team lead.
Clearly communicate and work with representatives from cross-functional teams including representatives from Regulatory Affairs, Quality, R&D and Marketing.
Prepare Labeling electronic Files/Folders containing labels to be revised or created, including supporting documentation for review – Including redlining and editing documents using MS Word and Adobe Acrobat.
Creation and routing of Change Requests for labels using the Electronic Documentation Management System and change control software.
Proofread to ensure accurate implementation of redlines.
Supports bar code scanning activities and documentation.
Supports the labeling work stream for revisions to medical device product labeling.
Track and monitor the approval and rework of labeling.
Assist personnel with locating specifications, project documentation, drawings, etc.
Work in a highly regulated environment.
Required Qualifications:
2-year Associates Degree or higher, required.
1-3 years of job-related experience working in the medical device field (preferably in Labeling).
A working knowledge in the use of a personal computer and mid-high level keyboarding skills.
Proficiency in Microsoft Word, Excel, PowerPoint, Outlook (email/meetings), Teams, and Acrobat Adobe
Knowledge of medical products, labeling FDA/ISO standards preferred or experience in a regulated field.
Familiarity with technical wording and documentation.
- Ability to apply common sense understanding to carry out instructions furnished in oral, written, or diagram form. Ability to solve practical job-related problems or recognize the need to ask supervision for assistance.
- Excellent oral and written communication skills in English are required
Preferred Skills:
- Bachelor Degree or Higher preferred
Bilingual Spanish a desirable additional skill.
- Basic mathematical abilities of addition, subtraction, multiplication, and division are required. Some ability to apply basic concepts of basic algebra and geometry are desirable.
PHYSICAL DEMANDS
Required to sit, talk, hear, stand, bend, reach with hands, lift or move up to 25 lbs. (archive record boxes). Vision requirements include ability to see and interact with a computer.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
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