Description:
The EU MDR Labeling Lead will be responsible for coordinating all activities related to implementing EU MDR Labelling requirements for medical device product labels, instructions for use (IFUs) and Patient Implant Cards and Patient Information Leaflets. The EU MDR Labeling Lead will be responsible to obtain and consolidate label content and input from cross functional EU MDR team members including Regulatory, Product Development and Medical/Clinical. This individual will be responsible for overseeing and delivering labelling redlines for multiple product lines with the objective to complete all required labeling updates for each MDR application.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across EUMDR project teams and sites for all impacted labeling components
- Coordinate and consolidate labeling content changes provided by cross-functional partners, complete label redlines and execute all associated redline documentation
- Support label content translation and verification process
- Maintain and ensure adherence to all EUMDR labeling project timelines and deliverables
- Develop knowledge and understanding of EU MDR labeling requirements and apply to all future EU MDR labeling projects
DESIRED MINIMUM QUALIFICATIONS
- Experience coordinating the process to edit and revise product labeling
- Ability to collaborate well with cross-functional business partners across a large matrix organization
- Strong attention to detail
- Strong organizational and project management skills
- Aptitude for learning new software and systems
- Ability to acknowledge issues or problems and work quickly to identify solutions
- Knowledge of core Microsoft Office software including Word, PowerPoint, Excel and Project
EDUCATION:
- 2-3 years of experience, ideally in medical device or pharmaceutical labeling development
PLUS: Production Experience
Location: 100% remote (pref someone local to NJ and could be hybrid onsite)
Remote in NJ: Labeling Lead (233257)
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