Regulatory Affairs/Quality Assurance Officer
BIOVIC SDN BHD
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.
- 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.
- 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.
- Provide advice, guidance and information to other Biovic personnel pertaining or relating to quality system/regulatory activities.
- 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.