A Senior Project Manager is mainly responsible for –

• (a)planning, developing, monitoring, evaluating and overseeing the daily operation of the Medical Device Administrative Control System (“MDACS”) related to the control/regulation of medical devices including the development of Guidance Notes, Technical References, Codes of Practice, and Operating Procedures, etc. and listing of medical devices, conformity assessment bodies, LRPs, local manufacturers, and importers;
• (b)conducting gap analysis among MDACS, WHO GBT + MD, other countries’ regulatory systems for development of a Regional Regulatory System for regulation of medical devices in Hong Kong in accordance with WHO GBT + MD;
• (c)assisting in the preparation of legislative proposal for the statutory regulation of medical devices;
• (d)planning, designing and developing the Medical Device Division (“MDD”) and/or Centre for Medical Products Regulation (“CMPR”) website, various database systems, computerized management and control system as required for MDD and/or CMPR daily operation of the medical devices regulation in accordance with WHO GBT + MD requirements;
• (e)assisting CMPR’s accreditation of WHO GBT + MD maturity level 4 and WHO Listed Authority in medical devices regulatory system including development of Quality Management System and Risk Management System; and
• (f)overseeing the publicity and consultation programme and organization of workshops/seminars for liaising, cultivating and maintaining working relationship with traders, healthcare organizations, international forums, other stakeholders and the public in relation to regulation of medical devices.

(Remarks: Successful candidate will be required to perform outdoor duties/site visits. Working venues and hours may vary depending on operational needs of the Department. May be required to work on shifts.)

Candidates should –

• (a)be a Corporate Member of the Hong Kong Institution of Engineers (Electronics Discipline or Biomedical Discipline) elected after 5 December 1975, or equivalent;
• (b)have at least 10 years’ post-qualification experience in the following areas of which at least 5 years should be in a supervisory position:
  • (i)regulation of medical devices, including pre-market control of development of Guidance Notes, Technical References, Codes of Practice and Operating Procedures, post-market surveillance of safety alert and adverse event; and
  • (ii)recognition of conformity assessment bodies; listing programmes of medical devices and local responsible persons, local manufacturers, and importers; and the planning and conduction of assessment and surveillance visits to the parties concerned;
• (c)preferably be familiarized with:
  • (i)other countries’ medical devices regulatory systems;
  • (ii)international organizations’ medical devices regulatory standards such as World Health Organization Global Benchmarking Tool plus Medical Devices (“WHO GBT + MD”) and International Medical Device Regulators Forum’s documents;
  • (iii)Quality Management System, Risk Management System and Occupational Safety and Health Management System; and
  • (iv)medical devices classification, principle of operation, clinical applications, safety, quality and efficacy; and
• (d)preferably have a good command of spoken and written Chinese and English.