Job Purpose:
• Reponsible for international registrations for Arjo products within a designated region
• To ensure that Arjo´s products are compliant to current regulations governed by the Regulatory Affairs Team and that current and future regulations are taken into account in the product development, registration, post market and change management processes.
• To develop, establish and maintain the regulatory strategies for approval of products and ensure regulatory requirements are aligned to achieve rapid market clearance.
• To be a trusted and relailble Regulatory Affairs partner supporting the stakeholders in regulatory functions.
Main responsibilities:
Product Compliance
General:
• Prepare product registration documentation for new and amended products licences for medical devices.
• Perform impact assessments on product design, engineering change and management system planning process outputs and updated...
