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Senior Associate in Medical Device/Medical Technology

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Date: 30-Sep-2021

Location: Outram Campus, SG

Company: National University of Singapore

Job Description

The Centre of Regulatory Excellence (CoRE) at Duke-NUS Medical School was formed in 2014 and provides a neutral academic platform for networking of health products regulatory stakeholders to promote capacity development, system strengthening and policy innovation in the Asia Pacific, with a focus on South-East Asia.

The selected candidate will contribute to the growth of the Centre in nurturing capabilities of the regulatory profession for the region, including National Regulatory Authorities, industry and researchers, through a comprehensive education portfolio.

  • Develop and lead the education initiatives of the Centre to achieve quality and consistency in regulatory training for Asia Pacific, in the domain of medical devices and technology
  • Guide on the content, relevance and format of the regulatory training programme, and ensure the materials of the programme are of the required professional standard
  • Contribute to the development of the content materials and alignment to current competency expectations and skills development framework
  • Establish a network of relevant regulatory experts in the domain of medical devices and technology
  • Work effectively with outside stakeholders to identify training needs and relevant areas of training
  • Lead the needs analyses, prioritise learning needs and develop regulatory training roadmaps for medical devices and technology
  • Identify and engage regulatory experts; maintain a network of key opinion leaders and content contributors
  • Construct learning materials according to the organisation’s delivery methodology
  • Design measures of programme effectiveness and monitor progress of regulatory training programmes
     

Qualifications

  • Degree in life sciences, biomedical sciences, biotechnology including bioengineering
  • Post-graduate degree will be an advantage
  • Minimum 2 years of recent experience covering the regulation and evaluation of medical devices and technology
  • Active participation, contribution, track record and recognition of expertise, ranging from publications, lectures and/or representation in regional and international boards and committees
  • Managing regulatory policies, processes and/or training in the organisation, in particular for medical devices and technology
  • Adept in facilitating high-level discussions with effective communication and writing skills
  • Accreditation from relevant external organisations e.g. Regulatory Affairs Professionals Society (RAPS) will be an advantage

We regret that only shortlisted candidates will be notified.