Keepmeposted

Medical Devices Registered Person (MDRP)

  • Basis:  Full/Part-Time
  • Closing Date:  08 Dec, 2022
  • Job Ref:  KMP-77210

Job Description

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.