職責
高級項目經理的主要職責包括－
(a) 就醫療儀器行政管理制度(“上述管理制度”)規劃、制訂、監察、評估及監督與管制／規管醫療儀器相關的日常運作，包括制訂指引、技術參考、業務守則及操作程序，以及醫療儀器、認證評核機構、本地負責人、製造商和進口商的表列工作；
(b) 對上述管理制度、世衞評估工具+醫療儀器、其他國家的規管制度進行差距分析，望能按照世衞評估工具+醫療儀器訂立本地規管制度規管本港的醫療儀器；
(c) 協助擬備立法建議立法規管醫療儀器；
(d) 按照醫療儀器科及／或香港藥物及醫療器械監督管理中心(“藥械監管中心”)日常規管醫療儀器的運作需要，並根據世衞評估工具+醫療儀器的規定，就醫療儀器科及／或藥械監管中心的網站、各資料庫系統、電腦化管理及控制系統進行規劃、設計及開發工作；
(e) 從事開發品質管理系統及風險管理系統等工作，協助藥械監管中心取得認可，成為世衞評估工具+醫療儀器成熟程度第四等級並成為世界衞生組織規管醫療儀器的表列機構；以及
(f) 統籌宣傳和諮詢計劃，以及籌辦工作坊／研討會，藉此與商戶、醫療機構、國際論壇、其他持份者就醫療儀器的規管工作建立及維繫工作關係，並與公眾人士保持聯繫。
(備註： 受聘人須執行戶外職務╱現場視察。工作地點及時間因應本部門的運作需要而定，可能須輪班工作。)
(a) 就醫療儀器行政管理制度(“上述管理制度”)規劃、制訂、監察、評估及監督與管制／規管醫療儀器相關的日常運作，包括制訂指引、技術參考、業務守則及操作程序，以及醫療儀器、認證評核機構、本地負責人、製造商和進口商的表列工作；
(b) 對上述管理制度、世衞評估工具+醫療儀器、其他國家的規管制度進行差距分析，望能按照世衞評估工具+醫療儀器訂立本地規管制度規管本港的醫療儀器；
(c) 協助擬備立法建議立法規管醫療儀器；
(d) 按照醫療儀器科及／或香港藥物及醫療器械監督管理中心(“藥械監管中心”)日常規管醫療儀器的運作需要，並根據世衞評估工具+醫療儀器的規定，就醫療儀器科及／或藥械監管中心的網站、各資料庫系統、電腦化管理及控制系統進行規劃、設計及開發工作；
(e) 從事開發品質管理系統及風險管理系統等工作，協助藥械監管中心取得認可，成為世衞評估工具+醫療儀器成熟程度第四等級並成為世界衞生組織規管醫療儀器的表列機構；以及
(f) 統籌宣傳和諮詢計劃，以及籌辦工作坊／研討會，藉此與商戶、醫療機構、國際論壇、其他持份者就醫療儀器的規管工作建立及維繫工作關係，並與公眾人士保持聯繫。
(備註： 受聘人須執行戶外職務╱現場視察。工作地點及時間因應本部門的運作需要而定，可能須輪班工作。)
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.)
(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.)
入職條件
申請人必須－
(a) 為1975年12月5日以後選出的香港工程師學會(電子或生物醫學界別)正式會員，或具備同等資格；
(b) 取得有關資格後最少10年從事下列領域的工作，其中最少5年擔任主管職位︰
(i) 醫療儀器的規管工作，包括醫療儀器推出市面前的管制工作，例如制訂指引、技術參考、業務守則及操作程序，以及醫療儀器推出市面後有關安全警示及醫療事件的監察工作；以及
(ii) 認證評核機構的認可工作；跟進醫療儀器連本地負責人、本地製造商和進口商的表列計劃工作；以及籌劃並進行對相關方面的評估和監控巡查工作；
(c) 熟悉以下相關資料者，可獲優先考慮︰
(i) 其他國家的醫療儀器規管制度；
(ii) 國際組織的醫療儀器規管標準，例如世界衞生組織全球基准評估工具+醫療儀器(“世衞評估工具+醫療儀器”)及國際醫療器械監管機構論壇的文件；
(iii) 品質管理系統、風險管理系統及職業健康及安全管理系統；以及
(iv) 醫療儀器分級、運作原理、臨牀用途、安全性、品質及效能方面的知識；以及
(d) 具備良好中、英文口語及書寫能力可獲優先考慮。
(註：申請人須提交有關修業證書／成績單及工作經驗的證明文件副本。)
(a) 為1975年12月5日以後選出的香港工程師學會(電子或生物醫學界別)正式會員，或具備同等資格；
(b) 取得有關資格後最少10年從事下列領域的工作，其中最少5年擔任主管職位︰
(i) 醫療儀器的規管工作，包括醫療儀器推出市面前的管制工作，例如制訂指引、技術參考、業務守則及操作程序，以及醫療儀器推出市面後有關安全警示及醫療事件的監察工作；以及
(ii) 認證評核機構的認可工作；跟進醫療儀器連本地負責人、本地製造商和進口商的表列計劃工作；以及籌劃並進行對相關方面的評估和監控巡查工作；
(c) 熟悉以下相關資料者，可獲優先考慮︰
(i) 其他國家的醫療儀器規管制度；
(ii) 國際組織的醫療儀器規管標準，例如世界衞生組織全球基准評估工具+醫療儀器(“世衞評估工具+醫療儀器”)及國際醫療器械監管機構論壇的文件；
(iii) 品質管理系統、風險管理系統及職業健康及安全管理系統；以及
(iv) 醫療儀器分級、運作原理、臨牀用途、安全性、品質及效能方面的知識；以及
(d) 具備良好中、英文口語及書寫能力可獲優先考慮。
(註：申請人須提交有關修業證書／成績單及工作經驗的證明文件副本。)
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.
(Note: Candidates should submit a copy of academic certificates/ transcripts and documentary proof of working experience.)
(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.
(Note: Candidates should submit a copy of academic certificates/ transcripts and documentary proof of working experience.)
