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.