Specialist, Document Management
Listed on 2026-09-12
-
Business
Regulatory Compliance Specialist
Company Description
Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
For more information about Abb Vie, please visit us at Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.
Job DescriptionServes as the Subject Matter Expert for documentation support activities including: document formatting, and change request review and approval facilitation.
Responsibilities:
- Maintain controlled medical-device documentation in compliance with ISO 13485 and Good Documentation Practices (GDP), ensuring accurate entries, proper approvals, revision control, distribution, and archiving.
- Review batch records for completeness, accuracy, legibility, traceability, and compliance with approved procedures before product release.
- Required
Education:
High School diploma or equivalent;
Preferred Education:
Bachelor's Degree - Preferred Experience:
Knowledge and hands-on experience with Document Management Systems;
Experience in detail-intensive and customer-focused environments;
Excellent organizational skills, attention to detail, and strong oral and written communications skills;
Word processing knowledge and experience with Microsoft Office products
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
- The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this roleat thetimeofthis posting based on the job grade for this position.
Individual compensation paid within this range will depend on many factors including geographic location,andwemay ultimately pay more or less than the posted range. This range may be modified in thefuture. - We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note:
No amount of payis considered to bewages or compensation until such amount isearned, vested, and determinable.
Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company'ssoleandabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent with applicable law.
Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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