Regulatory Affairs Project Specialist will assure support for CEE region, Medical Devices branch.
The main focus of the RA Project Specialist will be on Transformation projects and all regulatory activities associated with them. To ensure compliance of regulatory procedures for the Czech Republic, Slovakia and Hungary.
• Executes all regulatory activities on country level necessary to complete transformation projects.
• Participates on all projects related to portfolio transformation, supports the project manager and project team.
• Ensures regulatory compliance of consolidated medical devices with local regulations - responsibility for coordination and preparation of regulatory product notifications and registrations within the projects in given timelines.
• Responsible for various approvals in the Systems linked to job duties.
• Provides Regulatory support for business continuity and development.
• Responsible for copy review assessment and approval of our client´s MDs materials.
• Provides routine communication and updates to site and organizational management regarding projects.
• Ensure compliance of regulatory documents and procedures.
• Responds to product information requests.
• Provides Regulatory Affairs support during internal and external audits.
• Maintains regulatory tracking databases, including data entry, updates, and retrieval.
• Ensures readiness of local Regulatory Affairs department.
• Performs other work-related duties as assigned by manager.