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Regulatory Affairs/Quality Assurance Officer

BIOVIC SDN BHD

MYR 2,500.00 - MYR 4,000.00

JOB DESCRIPTION

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.


JOB REQUIREMENT

  • 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.

BIOVIC SDN BHD

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