Regulatory Affairs Executive

2 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia E-MESH (VN) CO LTD Full time 250,000 - 800,000 per year

Location: Kuala Lumpur, Malaysia

Industry: Medical Devices, Laboratory & Veterinary Products

Level: Mid-Level Employment

Type: Full-Time Position

We are seeking a competent and detail-driven Regulatory Affairs Executive to manage regulatory compliance for our medical, laboratory, and veterinary product portfolio in Malaysia. This role is responsible for coordinating product registrations, regulatory submissions, renewals, and ongoing compliance with the Medical Device Authority (MDA), NPRA (where applicable) and related regulatory bodies.

Key Responsibilities:

  • Prepare, compile, submit and maintain product registrations with the Malaysian Medical Device Authority (MDA).

  • Handle veterinary product regulatory submissions with relevant authorities (e.g. DVS, NPRA if applicable).

  • Manage renewals, amendments, variations and changes to registered products.

  • Monitor updates to Malaysian regulatory requirements and ensure company compliance. - Liaise with regulatory authorities, conformity assessment bodies (CAB), principals and consultants.

  • Prepare and maintain CSDT, technical files and dossiers.

  • Support GDPMD, ISO 13485 and internal/external audits.

  • Review labels, IFUs, packaging and promotional materials for regulatory compliance.

  • Coordinate post-market surveillance, adverse event reporting, recalls and field safety corrective actions (FSCA).

  • Maintain accurate regulatory documentation and databases.

  • Support Sales, Marketing, and Service teams on regulatory-related matters.

  • Perform any other regulatory-related duties as assigned by Management.

Requirements & Qualifications:

  • Minimum Bachelor's Degree in Biomedical Science, Pharmacy, Life Science, Engineering, Veterinary Science or related discipline.

  • 3–5 years of regulatory affairs experience in medical devices, laboratory or veterinary products.

  • Knowledge of Medical Device Act 2012, GDPMD, ISO 13485.

  • Experience in CSDT preparation and CAB submissions.

  • Strong documentation, coordination and communication skills.

  • Proficient in Microsoft Office.

  • Good command of English and Bahasa Malaysia.

Benefits & Perks:

  • Competitive salary

  • Medical benefits

  • Annual & medical leave

  • Training & career development

  • Career growth opportunities

Job Types: Full-time, Permanent

Pay: RM4, RM5,000.00 per month

Benefits:

  • Opportunities for promotion
  • Professional development

Work Location: In person

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