Description:
Key Responsibilities:
Regulatory & Compliance (Core Focus)
- Maintain and enhance the Quality Management System (QMS) in line with ISO 13485 .
- Ensure all departments comply with ISO procedures , keeping documentation audit-ready.
Manage SAHPRA license compliance and update medical device files with current certifications.
Oversee corrective actions, risk assessments, and supplier database updates .
Liaise with suppliers, customers, and industry bodies to ensure regulatory compliance.
Assist in product registrations, failure reporting, and returns processing .
Operations & Stock Control
- Support import/export compliance and assist with stock takes & cycle counts .
- Update supplier price lists and manage custom product procurement.
Financial & HR Support
- Assist with fleet management, creditor payments, and financial reporting .
- Maintain employee records, leave registers, and recruitment coordination .
Requirements:
- Maintain and enhance the Quality Management System (QMS) in line with ISO 13485 .
- Ensure all departments comply with ISO procedures , keeping documentation audit-ready.
Manage SAHPRA license compliance and update medical device files with current certifications.
Oversee corrective actions, risk assessments, and supplier database updates .
Liaise with suppliers, customers, and industry bodies to ensure regulatory compliance.
Assist in product registrations, failure reporting, and returns processing .
- Support import/export compliance and assist with stock takes & cycle counts .
- Update supplier price lists and manage custom product procurement.
- Assist with fleet management, creditor payments, and financial reporting .
- Maintain employee records, leave registers, and recruitment coordination .
- 3+ years of administrative experience (preferably in medical devices/healthcare supply).
- ISO 13485 experience (or strong familiarity with medical industry compliance).
- Fluent in English with strong documentation skills.
- Senior Certificate (Matric) – Tertiary qualification is a plus.
- South African citizen.
- 3+ years of administrative experience (preferably in medical devices/healthcare supply).
- ISO 13485 experience (or strong familiarity with medical industry compliance).
- Fluent in English with strong documentation skills.
- Senior Certificate (Matric) – Tertiary qualification is a plus.
- South African citizen.
03 Apr 2025;
from:
careers24.com