Pay Range: $40/hr-$45/hr

About the Role

• This position is responsible for managing regulatory labeling deliverables across various project types, including submissions, new product development, sustaining, launches, and manufacturing transfers.
• The role requires expertise in EU and global labeling requirements, project management, and change management skills.

Responsibilities

• Accountable for regulatory labeling deliverables for diverse projects.
• Manage and support the assessment and creation of templates for new and changing requirements. - Prepare technical product documentation, including plans, reports, and engineering change orders.
• Maintain artwork content for all labeling types, ensuring compliance with applicable regulations, standards, and internal requirements.
• Estimate labeling project efforts, resource requirements, and collaborate with stakeholders to understand project scope.
• Collaborate with multi-functional teams to facilitate the completion of labeling artwork projects.
• Track labeling project schedules, identify risks/issues, determine resolutions, and communicate project status or escalations.
• Stay updated on regulatory procedures and changes.
• Manage labeling, UDI, and barcode grading processes and systems related to product labeling.
• Perform other duties as assigned or required.

Education Qualification

• Master's degree in Science, Engineering, or Regulatory.

Required Skills

• 5-9 years of relevant experience.
• Strong understanding of EU labeling requirements and global labeling standards, including 21 CFR 801, EU MDR Regulation, ISO15223, and ISO20417.
• Proficient in project management and change management.
• Ability to collaborate with cross-functional teams.
• Strong communication and organizational skills.
• Ability to work independently with general supervision on moderately complex projects. 

Benefits

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.