An established importer and distributor of medical devices are looking to engage an MDRP on a part-time or full-time basis. The chosen candidate shall act as the officially registered company MDRP.
Key responsibilities will include but are not limited to:
- Leading the company’s Quality and Compliance team.
- Ensuring that medical devices placed on the market comply with all relevant legislation.
- Retaining all relevant documentation related to all medical devices.
- Ensuring that all devices are registered in the EUDAMED and notified in the national medical device database.
- Ensuring that the company’s quality system is properly administered and can consistently support the fulfilment of all legal requirements.
- Ensuring that while a device is under his/her responsibility, storage and transport conditions comply with the general safety and performance requirements found in the legislation as well as the conditions set by the manufacturer.
- Ensuring that an appropriate level of traceability of devices is kept by means of detailed documentation and record-keeping systems.
- Ensuring complaints and incident reports from healthcare professionals, patients or users are forwarded to manufacturers, authorised representatives and the national competent authority as applicable.
- Liaising with manufacturers in collecting information and dealing with preventive, corrective and field safety corrective action.
- Informing the national competent authority if a device is believed to present serious risk or is suspected to be falsified.
- Coordinating recalls and keeping a register of complaints, non-conforming devices, recalls and withdrawals.
Skills and qualifications:
- MDRP Registration issued by the Malta Medicines Authority.
- Excellent problem-solving skills.
- Highly organised.
- Strong organisational, communication and interpersonal skills.
- Self-motivated and goal-oriented.
- Knowledge of MS Office software.
Kindly note that your application will be sent directly to the employer of this vacancy.
Keepmeposted – KMP-77210