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.
Share our passion. Join our team!
Are you looking for an exciting career opportunity? We are seeking to recruit an experienced and highly motivated Quality and Regulatory Officer to join our dynamic Regulatory Affairs team on a full-time basis. Reporting directly to the Head of Regulatory Affairs, the selected candidate will handle day-to-day regulatory functions in accordance with relevant industry legislation and aid and support the Regulatory Affairs Department.
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
- Assist the Regulatory Affairs Department and RP Office to maintain the Quality System in line with GDP regulations and Medical Device/In-Vitro Medical Device regulations;
- Respond to and deal with MAHs and customer communication;
- Manage the drafting, compilation, filing and storage of documents;
- Update, renew and disseminate internally Controlled Documents and SOPs;
- Manage SOP training completion and follow-ups;
- Manage the process of translating product information – coordinating translations requests from MAHs and ensuring dissemination for Medical Review;
- Perform monthly reconciliation of product quality complaint, adverse events, medical enquiries and provide literature screening reports;
- Verify and report adherence to the implemented company procedures;
- Verify temperature data related to storage and distribution;
- Assist the Responsible Persons, PV and RA Manager, and MDRPs to meet set deadlines;
- Assist the Regulatory Affairs Department with other general administrative duties as required.
Skills and Competences
- A life science qualification, preferably a BSc. in Pharmaceutical Technology;
- Experience in a similar role and knowledge of pharmaceutical regulatory requirements will be considered advantageous;
- Be conversant in all Microsoft Office applications;
- Effective communication and interpersonal skills;
- Organized and meticulous with an eye for detail;
- Capable of meeting deadlines and working under minimum supervision.
- Ability to work independently and as part of a team.
Why Join Us:
- Opportunity to work with a leading healthcare company.
- Supportive team environment with opportunities for professional development and career growth.
- Modernised premises with free on-site parking facilities.
- Flexible working environment.
If you are ready to take the next step in your career, we want to hear from you! Apply now by sending your CV and covering letter to:
For more information about how we process your personal data throughout the recruitment process, please refer to our Job Candidate Privacy Notice via this link: https://ammangion.com.mt/privacy-notice-job-candidates/