تفاصيل الوظيفة
Responsible for overseeing the Regulatory Affairs Department across IMDAD branches and ensuring the application of the quality management system (QMS) in line with the ISO 13485 standard. Job Responsibilities Regulatory Affairs:
- Ensure compliance with regulatory bodies in KSA and other operating countries for product marketing approval, importation, warehouses, and all required governmental registrations.
- Direct and coordinate activities related to the submission and approval of products to regulatory bodies.
- Provide guidance to internal stakeholder project teams on regulatory compliance issues.
- Manage coordination between internal stakeholders, including the Supply Chain Department, Client Success Department, and Technology and Business Solutions.
- Lead and supervise the preparation and maintenance of regulatory submissions and files across the group.
- Ensure adherence to standard operating procedures for the timely approval of new products and regulatory support for marketed products.
- Consult with management to prepare appropriate regulatory filings for product approval.
- Collaborate with internal and external stakeholders to oversee the regulatory aspects of new product launches, application submissions, and the assessment of regulatory license status due to product changes.
- Lead, train, develop and retain regulatory affairs team members to ensure competence and compliance with industry standards.
- Serve as the primary liaison between SFDA and IMDAD KSA
- Provide monthly status reports on the products.
- Ensure that equipment and consumables adhere to regulatory bodies’ regulations.
- Update registrations in accordance with relevant legislation, regulations, and guidelines
- Coordinate with suppliers regarding equipment specifications and documentation
- Track and ensure timely payment of applicable fees and renewal of all licenses.
- Maintain warehouse license.
- Stay closely updated on regulatory bodies' announcements to comply with any changes to interim regulations across IMDAD branches.
- Implement an agile framework across Imdad’s branches and departments to optimize regulatory workflow.
- Serve as the Quality Management Representative responsible for maintaining the QMS of KSA.
- Host and manage SFDA and notified bodies audits.
- Ensure that the QMS processes are established, implemented, and maintained to meet standards.
- Record minutes of management meetings, advise management on any product or process-related issues, and make recommendations for improvements.
- Plan and oversee internal audit activities and implement audit corrective actions.
- Manage the CAPA process, ensuring the establishment of corrective actions and completion of root-cause elimination for identified issues.
- Responsible for the Document Control process and the effective management of all documentation required by regulatory agencies.
- Define necessary quality metrics and coordinate data collection from various functions.
- Report the status of QMS performance to the direct manager.
- Ensure that the QMS Objectives comply with the ISO 13485 standard.
- Maintain appropriate records of any delegated duties.
- Ensure compliance with Good Distribution and storage practices.
- Supervise RA’s and QA’s specialists.
- Demonstrate skills in project management, leadership, communication, and presentations.
- Identify issues and minimize regulatory risks through creative problem-solving.
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