IVDR Documentation Specialist

SUMMARY:
Our client based in Brackenfell, is currently looking for a Supplier Quality IVDR Documentation Specialist to be based in Brackenfell, Western Cape.

POSITION INFO:
Position: Supplier Quality IVDR Documentation Specialist

Location: Brackenfell, Western Cape

Employment Type: 12 Months (Limited Duration Contract)

Job Summary:

As a Supplier Quality IVDR Documentation Specialist, you will serve as the primary liaison between Supplier Quality, Procurement, and suppliers, ensuring the seamless coordination and management of all documentation required for In Vitro Diagnostic Regulation (IVDR) submissions. You will also play a vital role in related supplier quality activities, supporting the organization in driving compliance, efficiency, and continuous improvement in supplier quality processes.

Minimum Qualifying Criteria:

• Bachelor’s or Master’s Degree in Life Sciences, Data Science, or related field.
• Alternatively, completed training as a communication/documentation specialist, technician, or laboratory technician with equivalent relevant experience.
• Strong analytical and risk-based thinking skills.
• Excellent communication skills in English (both written and verbal).
• Proficiency in Google Workspace and SAP.
• Strong interpersonal skills and attention to detail.
• Experience in the med-tech sector or knowledge of production, document management, and quality systems (ISO13485, ISO9001, IVDR).
• German language proficiency.

• Coordinate, organize, and manage supplier IVDR documentation for verification activities.
• Support IVDR verification and related tool management processes.
• Act as the main point of contact between suppliers, Supplier Quality, Procurement, and other stakeholders regarding IVDR documentation.
• Assist with Supplier Corrective Action Requests (SCARs) and supplier onboarding processes.
• Monitor supplier performance and assist in audit preparation.
• Contribute to other supplier quality initiatives as required.