Regulatory & QMS - Medical Device

Job Description:

  • To manage the entire process of product registration of current and new products with various local regulatory bodies.
  • Stay updated of new applicable laws with the Medical Devices Authority (MDA).
  • Creating and maintaining the copy filing system for organisational records.
  • Ensure quality system implementation is accordance to ISO and GDPMD standards.
  • Advice the management with updates on how the changes will affect the business, and create compliance strategies for newly developed products.
  • Assist in all administration jobs related to Regulatory and Quality Assurance matters.


  • We are looking for a candidate that graduated with a Bachelor’s degree in the area of Life Sciences (e.g. Biomedical Science, Biotechnology, Pharmacy or Equivalent).
  • Candidate must possess at least 2 Year(s) of working experience.
  • A good understanding and knowledge of GDPMD, ISO 13485, ISO 9001, ISO 15189.
  • Having experience in Product Registration with MDA.
  • Willingness to learn/read about the products (technical product manuals, clinical reprints/reports etc.).
  • Hard-working and self-confident to meet and interact with senior status decision makers (private and government healthcare officers).
  • Has own transport and able to travel within the KL/ Klang Valley.