Job Description

HM's Top Needs:
1.  EU Labeling Requirements
2. Global labeling requirements, 21 CFR 801, EU MDR Regulation, ISO15223, ISO20417
3. Project Management and Change Management skills

• Accountable for the regulatory labeling deliverables for various project types (i.e. submission, new product development, sustaining, launches, manufacturing transfer, etc.)
• Manage and support assessment and template creation for new and changing requirements.
• Prepare technical product documentation including plans, reports, and engineering change orders, etc.
• Maintain artwork content for all labeling types including Instructions for Use documents, product labels, Patient labeling, electronic labeling, label stocks, and carton in compliance with applicable regulations, standards, company policies, processes as well as internal labeling requirements.
• Estimates labeling projects level of effort, resource requirements and works with stakeholders to understand the scope of effort and tasks necessary to complete the project.
• Collaborate with multi-functional team (R&D engineering, marketing, manufacturing, operations, regulatory, legal, quality, clinical, medical safety) to facilitate completion of labeling artwork projects
• Tracks labeling project schedules, identify risks/issues, determine resolution and communicates project status or escalations by participating in departmental and project team meetings.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Manage labeling, UDI and barcode grading processes and systems as related to product labeling
• Other duties as assigned or required

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