Regulatory Affairs Specialists at Arthrex responsible for managing regulatory approval for medical devices. Join a global medical device company focused on innovative education and development.
About the role
- Regulatory Affairs Consultant providing regulatory input for EU product labelling and promotional materials. Collaborating with cross-functional teams in various European locations.
Responsibilities
- Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements
- Serve as the key point of contact for EU Product Information for both internal and external stakeholders
- Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs
- Deliver competitive labelling searches and contribute to TLP for early development assets
- Ensure timely tracking and management of all EU Product Information in appropriate systems
- Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports
- Coordinate Linguistic Review processes with LR Coordinator according to SOPs
- Communicate proactively with the Artworks team for artwork and mock-up changes, participating in Change Control Processes
- Lead the Local Labelling Committee for creation, review and approval of EU Product Information
- Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials
- Build strong relationships with EU and Global Regulatory teams, local business partners
- Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements
Requirements
- University degree in a life science discipline
- Strong knowledge of EU regulatory requirements for product labelling and promotional materials
- Experience with electronic content management systems and regulatory SOPs
- Excellent project management and organizational abilities
- Outstanding written and verbal communication skills
- Proven ability to work effectively in cross-functional teams
- Fluent in English, written and spoken
Benefits
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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