Senior QA&RA Specialist | MedTech | Gauteng. Temp to Permanent Vacancy.

Senior QA & RA Specialist - MedTech, Gauteng

Location : Johannesburg, Gauteng, South Africa

Employment type : Contract (6‑month temporary contract with possibility of permanent employment)

Overview

Senior QA & RA Specialist responsible for ensuring compliance of CQA processes within the region, including complaint management, product surveillance, supplier / distributor controls, regulatory affairs, and QA system implementation.

Responsibilities

• Local Complaint Coordinator activity : establish and maintain processes for logging, investigating, notifying authorities, training staff, closing complaints, and ensuring backup training.
• Product Surveillance for Medicinal Products and Medical Devices : gather, record, transmit adverse events, report to authorities, maintain surveillance system, and coordinate with functional teams.
• Field Action execution : coordinate corrective actions, communicate with Ministry of Health and customers, ensure timely execution, reconciliation, closure, and backup training.
• Distributor & Supplier QA : manage assessment program, conduct audits, supervise corrective actions, train distributors, sign QA agreements, and maintain approved supplier list.
• Implementation and audit management of Quality System in the region, ensuring alignment with ISO 9001, ISO 13485, Corporate Quality Manual and change control procedures.
• NCR, CAPA and Change Management : investigate non‑conformances, initiate corrective and preventive actions, and manage change control process.
• Regulatory Development : proactively monitor national regulatory requirements, develop approval strategies, maintain good standing with regulators, and manage product registration life cycle.
• Training : maintain training records, train employees on quality systems, GDP, and SAHPRA guidelines.
• Compliance & Documentation : implement SOPs, manage preparation of new SOPs, ensure documentation meets Corporate Quality Manual and ISO standards.
• ERP System SME : expert on JDE / ERP distribution aspects, ensure backup training, and maintain region‑appropriate processes.
• Other quality aspects : manage temperature‑controlled shipments, maintain critical task backups, define and control quality aspects of third‑party warehouses, and establish sample rooms.
• Regulatory Affairs : annual product submission plan, oversee registration dossiers, liaison with authorities, manage post‑registration variations, coordinate inspections, and manage correspondence.

Qualifications

Benefits

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