Regulatory Affairs Specialist - Medical Devices

Shah Alam Permanent

Added 07/05/2021

  • Great career progression as part of a leading MNC and multiple avenues for the
  • Excellent salary and benefits

About Our Client

Our client is one of the largest global healthcare companies, with a well-established business in Malaysia.

Job Description

Key responsibilities will involve:

  • Managing the entire process for regulatory approval of medical devices
  • Analyse data for new product submissions
  • Implement regulatory plans and ensure submissions are done in a timely manner
  • Engaging with government bodies such as the MDA (Medical Device Authority) to ensure compliance with local guidelines
  • Regular reporting on registration status to management
  • Keep up-to-date on market trends and devise new registration strategies
  • Review advertising materials to ensure guidelines compliance

The Successful Applicant

Key requirements include:

  • Bachelor's degree in biotechnology, biomedical science, pharmacy, or a related discipline
  • Experience in regulatory affairs in a medical device or pharmaceutical company
  • Familiarity with local regulatory bodies such as the MDA (Medical Devices Authority) and NPRA (National Pharmaceutical Regulatory Agency
  • Strong initiative and ability to take the lead on projects

What's on Offer

  • Great career progression as part of a leading MNC and multiple avenues for the future
  • Excellent salary and benefits
  • Opportunity to build and expand a strong business into key regions assigned

Elijah Bepono
Quote job ref
Phone number
+603 2302 4052

Job summary

Contract Type
Consultant name
Elijah Bepono
Consultant contact
+603 2302 4052
Job Reference