HEAD MDRP

Job Description

Our client looking for a Head MDRP to join their Regulatory Affairs Department. This person must be duly registered as MDRP with the Malta Medicines Authority. This person will report directly to the Head of Regulatory Affairs and in turn will have one MDRP reporting into them.

Main duties and responsibilities

• Ensure that the Company is compliant with the industry’s applicable Medical Devices Regulations and local legislations, as well as, with the regulatory, quality and safety agreements with the Manufacturers or Suppliers;
• Design, setup and maintain an effective Quality Management System (QMS) for Medical Devices;
• Ensure an adequate inventory management system and efficient record keeping system to ensure traceability;
• Ensure compliance with GDP guidelines, including but not limited to, appropriate premises and equipment, training of personnel, appropriate storage conditions and adequate pest control system;
• Design and set-up of procedures in line with the roles and responsibilities of an Importer and Distributor;
• Compile and maintain a database of records, as required by EU regulations;
• Engage in product validation practices through EUDAMED portal;
• Handle return requests and product notifications to the local authorities;
• Organise disposal of goods/waste management;
• Report product complaints within specified timelines both to Manufacturers or Suppliers and local authorities;
• Assist both the Company’s suppliers and authorities in implementing corrective actions necessitated through post-market surveillance;
• Assist in Field Safety Corrective Actions;
• Handle recalls related to Medical Devices;
• Handle Qualification of Service Suppliers related to Medical Devices;
• Perform Internal Audits of relevant areas;
• Host Inspections and audits from local authorities and suppliers related to Medical Devices;
• Train, monitor and develop present and future MDRPs, also known as the Employee’s direct reports, and to direct them in meeting their work objectives;
• Any other duties that emerge from the guidelines issued by the Malta Medicines Authority, EU authorities and the Head of Regulatory Affairs;

Skills and competencies

• 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.