Regulatory Affairs Executive Port Klang/ Pontian

3 weeks ago


Malaysia Karex Industries Sdn. Bhd. Full time

Role Responsibilities

  • Ensure that company’s products comply with the applicable regulations.
  • Maintain and update national and international legislation, guidelines and customer practices.
  • Collect, collate and evaluate scientific data from a range of sources.
  • Develop and write clear arguments and explanations for new product license as well as license renewal.
  • Prepare submission of license variations and renewal approvals.
  • Monitor and set timeline for license variations and renewal approvals.
  • Write clear, accessible product labels and instruction leaflets.
  • Involved in post-market surveillance reporting as guided by the Senior Group RA Manager.
  • Advise R&D team on regulatory requirements and regulatory strategy.
  • Undertake and manage regulatory inspections and technical documentation audit.
  • Maintaining the technical documentation and EU declaration of conformity together with Senior Group RA Manager.
  • Review company practices and provide advice on changes / improvement to the system.
  • Liaise with and make presentations to regulatory authorities.
  • Negotiate with regulatory authorities for marketing authorization.
  • Specify storage, labelling and packaging requirements (Oversea countries like Taiwan and China).
  • Actively involved in company’s environmental initiatives.
  • Ensure that target agreed for the KPI’s under the responsibility of the position are achieved.
  • To ensure all other duties and projects as assigned by the superior are done.

Role Requirements

  • Candidate must possess at least a Bachelor’s Degree, Post Graduate Diploma, Professional Degree in Scientific Discipline.
  • At least 1-2 year(s) of working experience in the field of medical devices and regulatory affairs on medical devices.
  • Analytical and problem solving skills.
  • Required Language: Well versed in English, Bahasa Malaysia & Mandarin.
  • Full-time position(s) available.
  • Candidate must be willing to work in Port Klang, Selangor/ Pontian, Johor.

Submit your resume to
hr@karex.com.my
We regret that only shortlisted candidates will be notified.
Thank you and have a nice day

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