Head of Medical Device – Regulatory Affairs

• Quality Management System (QMS): Design, set up, and maintain an effective QMS for medical devices to ensure regulatory compliance and product quality.
• Inventory Management: Implement and oversee an adequate inventory management system and efficient record-keeping to ensure traceability of medical devices.
• Good Distribution Practice (GDP) Guidelines: Ensure compliance with GDP guidelines, including premises and equipment suitability, personnel training, storage conditions, and pest control.
• Importer and Distributor Procedures: Design and establish procedures in line with the roles and responsibilities of an importer and distributor of medical devices.
• Regulatory Documentation: Compile and maintain a database of records as required by EU regulations.
• Complaint Handling: Manage product return requests and notifications to local authorities, and report product complaints within specified timelines to manufacturers or suppliers and local authorities.
• Post-Market Surveillance: Assist in implementing corrective actions necessitated through post-market surveillance and handle Field Safety Corrective Actions and recalls related to medical devices.
• Supplier Qualification: Handle qualification of service suppliers related to medical devices to ensure quality and regulatory compliance.
• Internal Audits: Perform internal audits of relevant areas to identify areas for improvement and ensure compliance with regulations and standards.
• Inspections and Audits: Host inspections and audits from local authorities and suppliers related to medical devices.
• Team Development: Train, monitor, and develop present and future team members to meet their work objectives.
• Regulatory Guidelines: Stay informed about guidelines issued by regulatory authorities such as the Malta Medicines Authority and EU authorities, and ensure compliance with them.

• Bachelor’s degree or higher in a life science. Qualified Pharmacists suitably registered and licensed to practice in Malta and who can act as deputy Responsible Person (RP) will be given preference.
• Be duly registered as MDRP with the Malta Medicines Authority (MMA).
• Minimum 1 year of professional experience in Regulatory Affairs or in quality management systems related to medical devices.
• Excellent verbal and written communication skills.
• Be conversant in all Microsoft Office applications.
• Be a team player.
• Be self-disciplined and able to work to strict deadlines.

M Recruitment