Regulatory Affairs Assistant

7 days ago


Shah Alam, Selangor, Malaysia Bits Medical Sdn Bhd Full time

Responsibilities: -

  • Assist in ensuring company compliance with Medical Device Authority (MDA) requirements.
  • Support in Establishment Licensing and Medical Device Registration matters.
  • Liaise with overseas manufacturers for regulatory documentation.
  • Assist in the renewal of certificates and licenses accurately and on time.
  • Maintain and update regulatory records and files.
  • Support all departments in ensuring regulatory compliance and safety requirements.
  • Perform other related duties as assigned by the Regulatory Affairs Executive or Manager.

Qualification: -

  • Diploma or Degree in Biomedical Science, Pharmacy, Biotechnology, or related field.
  • Fresh graduates are encouraged to apply.
  • Basic understanding of MDA regulations is an advantage.
  • Good communication, coordination, and organizational skills.

Job Type: Full-time

Pay: RM2, RM3,000.00 per month

Benefits:

  • Free parking
  • Maternity leave
  • Opportunities for promotion
  • Parental leave
  • Professional development

Work Location: In person


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