Senior Regulatory Affairs Specialist EMA MPS
BD
مجموع سنوات الخبرة :13 years, 4 أشهر
Currently responsible for pre-market and post-market regulatory activities for all business units in Algeria, Morocco, Tunisia, Libya, Syria, Jordan, Lebanon, Iran and Iraq. Key responsibilities are:
-Maintaining pre-market submissions and ensuring that the latest data is available in the registration system
-Ensuring validity of licenses for Sales & Service operations (EC, Free Sales Certification, ISO 13485)
-Coordinating the communication between distributors and business regulatory stakeholders
-Analyzing and communicating changes, country regulations and future expectations to all stakeholders and implementing strategies
-Supporting custom clearance operations, coordinating submissions and tracking import permissions
-Partnering with business regulatory stakeholders to ensure all requirements for country submissions are met
-File and maintain regulatory deliverables
Maintaining pre-market and post-market regulatory activities for all business units in Turkey;
-Maintaining pre-market submissions and ensuring that the latest data is available in the registration system
-Maintaining post-market reportings to Turkish MoH, communicating post-market actions to customers and communicating the file closure to European Regulatory Stakeholders within BD
-Auditing third party suppliers from regulatory perspective, such as distributors' warehouses and logistics partners' warehouses
-Analyzing and communicating changes, country regulations and future expectations to all stakeholders and implementing strategies
-Partnering with business regulatory stakeholders to ensure all requirements for country submissions are met
Maintaining Pre Market regulatory processes of medical devices for TCA region:
• File and maintain regulatory deliverables
• Analyze and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies
• Support regulatory inspections as required
• Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and postmarket reporting through the development, maintenance and improvement of documented processes.
• Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions
• Communicate with Product RA to establish regulatory requirements
• Complete specific country testing and work with Product RA; arrange for test devices and support as needed.
• Partner with Product RA to review advertising and promotion materials for country or regional compliance and approve these as required.
• Act as liaison with external regulatory reviewers to gain rapid approval of submissions.
• Work with Product RA for countries with license expiration requirements; establish plan and deliverables for timely submission for renewal of license
Had to freeze the program due to moving to Dubai