MEDICAL DEVICE REGISTERED PERSON (MDRP)

The A.M. Mangion Group of Companies is an organization operating in Malta and the MENA region. We are leaders in the healthcare sector and pride ourselves in being a true partner of the world’s leading multinationals in the areas of Pharmaceuticals, Medical Devices, Consumer and OTC goods, Skin and Beauty Care. We are also a major player in the Pharmacy and Clinic business.

 

With more than forty years of experience in the healthcare sector, the A.M. Mangion Group is an environment of positive energy, focused on innovation and dedicated to enhancing life. Critical to us being able to achieve our mission is our ability to stay true to our core values these being Trust, Loyalty, Competence, Commitment and Accountability, this reigning true in not just our corporate realm but also in relation to our approach to people.

 

Are you looking for an exciting career opportunity? We are seeking an experienced and highly motivated individual to join our dynamic Regulatory Affairs team on full-time basis. Reporting directly to the Head of Medical Devices, the MDRP’s main responsibility is to ensure that the Company is compliant with the Medical Device Regulation.

 

As a valued member of our team, you’ll have the opportunity to contribute to our mission of enhancing patients’ lives and making a meaningful impact in the healthcare industry.

 

 

Main duties and responsibilities

 

  • Ensure compliance 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;
  • Assist with the design and maintenance of an effective Quality Management System (QMS) for Medical Devices;
  • Maintain an adequate inventory management system and efficient record keeping system to ensure traceability;
  • Ensure compliance with GDP guidelines, including but not limited to, training of personnel and adherence to appropriate storage conditions.
  • Assist with the 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 the EU regulations;
  • Engage in product validation practices through EUDAMED portal;
  • Handle product notifications to the local authorities;
  • Handle return requests;
  • 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 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;
  • Any other duties as directed by the Head of Medical Devices and/or the Head of Regulatory Affairs.

Requirements

  • Bachelor’s degree or higher in a Life Science;
  • Be duly registered as MDRP with the Malta Medicines Authority (MMA);
  • Minimum of 1 year of professional experience in Regulatory Affairs or in quality management systems related to medical devices;
  • Effective communication and interpersonal abilities;
  • Be conversant in all Microsoft Office applications;
  • Detail-oriented with strong organizational skills.

Why Join Us:

  • Opportunity to work with a leading pharmaceutical company.
  • Supportive team environment with opportunities for professional development and career growth.
  • Modernised premises with free on-site parking facilities.
  • Flexible working environment.

Kindly send your CV and covering letter by not later than 27th June 2024 to

hr@ammangion.com

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