Senior QA & Regulatory Lead – 6-Month Maternity Cover

Kinetic Business Solutions; Johannesburg; On-site; ZAR 500 000 - 600 000; Full time

Job summary

A leading Medical Device company in Johannesburg is seeking a Senior Quality Assurance & Regulatory Affairs Specialist for a 6-month maternity cover. This role involves facilitating technical information for product licensing, collaborating with teams to ensure regulatory compliance, and managing quality audits. The ideal candidate will have a Bachelor's degree in Pharmacy and 4–6 years of regulatory affairs experience. Strong organizational and proactive skills are essential.

Qualifications

• Minimum of 4–6 years of regulatory affairs experience.
• Good knowledge of QA and RA requirements, compliance regulations and industry practices.
• Motivated, proactive, dynamic, methodical, organized, and decisive.

Responsibilities

• Facilitates all related technical information and applicable documentation for licensing of products.
• Collaborates with cross-functional teams to address regulatory issues.
• Coordinates internal quality audits.
• Assists in developing a plan and implementation of a Quality Management System.
• Works closely with the Quality Management team for Quality-related matters.
• Provides support to the sales team and supply chain for tenders.
• Leads or supports RAQA projects and assignments.

Skills

Regulatory affairs experience

Knowledge of QA and RA requirements

Organizational skills

Proactive and dynamic

Education

Bachelor's Degree in Pharmacy

Job description

A leading Medical Device company in Johannesburg is seeking a Senior Quality Assurance & Regulatory Affairs Specialist for a 6-month maternity cover. This role involves facilitating technical information for product licensing, collaborating with teams to ensure regulatory compliance, and managing quality audits. The ideal candidate will have a Bachelor's degree in Pharmacy and 4–6 years of regulatory affairs experience. Strong organizational and proactive skills are essential.