Job Description

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Work Location: Helios, 11 Biopolis Way, Singapore 138667

Responsibilities

• Initiate the development of sound regulatory policy and deep scientific expertise, and to provide regulatory and scientific guidance in the field of medical devices
• Contribute and manage the team in scientific evaluation of medical devices and providing regulatory guidance to local medical device companies on innovative medical devices
• Train and mentor junior officers in developing the necessary analytical and scientific judgment skills
• Participate and actively contribute in regulatory collaborations and partnerships with overseas regulators, and in influencing the development of technical standards and requirements for innovative medical devices in national, regional and international arenas

• Possess knowledge and experience in related scientific disciplines, e.g., biomedical engineering, computer engineering, Information technology, Biomedical science
• Minimum 5 years' experience as a Senior Regulatory Specialist or similar scope of work in in medical device or relevant industry
• Deep scientific knowledge of the medical device field, including the scientific advancement and developments in this space, and the ability to provide strong and effective professional and scientific assessment
• Good knowledge on the regulatory considerations in medical device regulation, and the regulatory frameworks in major overseas markets e.g. US, EU, China, ASEAN
• Good level of competence in regulatory and policy development in medical device
• Experience in participating in international scientific advisory committees/workgroups for medical device preferred
• Experience in mentoring and training junior staff