Key skills
RProject ManagementCommunicationProblem SolvingNegotiation
About this role
Role Overview
- Provide advice and counsel on EU MDR, device labeling and global translation process
- Ensure compliance with SmPC & labeling requirements for pharmaceutical products in Europe
- Review/QC materials, author documents, meet submission timelines for assigned products
- Analyze competitor labeling for products to ensure competitive labeling
- Maintain awareness of relevant EU legislation and guidance
- Provide information for artwork briefs for EU production artwork
- Present updates/forecasts to stakeholders at regular meetings
- Lead or support project work related to device labeling improvements or compliance
- Manage device labeling in the RIM system
Requirements
- 5-7 years in Regulatory, R&D or related area
- 3 years in Regulatory preferred
- Experience in regulatory affairs device / drug product labeling
- European experience required
- Solid working knowledge of device labeling process
- Strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills
- Competent knowledge of EU regulatory guidelines pertaining to device and drug product labeling
- Must be able to work independently and be flexible with meetings on different time zones.
Benefits
- Health insurance
- Flexible work arrangements