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Regulatory Affairs/Quality Assurance Officer


MYR 2,500.00 - MYR 4,000.00


Maintain the quality system according to the applicable requirements and regulations. Liaise with Regulatory agencies for medical device registration in various regions and maintain compliance with Regulatory regulations/requirements. Maintain the company ISO documentation system.

Quality Assurance

  • To maintain the quality management system according ISO 13485 (2016) and other applicable regulatory requirements.
  • To review all device history records for accuracy and completeness.
  • Coordinate, oversee and participate in internal and external audits.
  • Collaborate with relevant internal counterparts to ensure quality system suitability and/or medical device compliance.
  • Coordinate and maintain company ISO documentation system.
  • Manage maintenance and surveillance audits by Notified Bodies, FDA etc.
  • Train on GMP and audits as necessary.
  • Coordinate and maintain CAPA and NCR systems for the company.

Regulatory Affairs

  • Prepare required documentation for submission to regulatory agencies that govern medical devices.
  • Ensure compliance with regulations set by local and international regulatory agencies for medical devices including packaging and labeling requirements.
  • Keep up to date with changes in regulatory legislation and guidelines.
  • Maintain familiarity with company products and clinical applications.
  • Coordinate pre-clinical and clinical studies required for regulatory submissions.
  • Manage market surveillance for Biovic’s products.
  • Ensure distributors are following regional regulatory requirements.

Resource Person

  • Provide advice, guidance and information to other Biovic personnel pertaining or relating to quality system/regulatory activities.

Relationship Building

  • Maintain positive relationships with internal colleagues and external customers/suppliers to support the smooth running of department and company operations.


  • Degree in Science or any related disciplines.
  • 1-2 years QA and Regulatory affairs working experience.
  • Quality assurance and regulatory affairs in a medical device manufacturing environment, working independently with minimal supervision.
  • Very good spoken and written English skills, accuracy, and attention to detail.


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