Senior Regulatory Affairs Specialist

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

Senior Quality Assurance & Regulatory Affairs Specialist (Maternity Cover)

Kinetic is working with a leading Medical Device company, hiring a Senior Quality Assurance & Regulatory Affairs Specialist to be based in Johannesburg.

This is a 6‑month maternity cover position.

Key aspects of the role include:

• Facilitates all related technical information and applicable documentation for licensing of products.
• Collaborates with cross‑functional teams to address regulatory issues and ensure compliance with regulatory standards, regulations, and guidelines.
• Coordinates internal quality audits.
• Assists in developing a plan and implementation of a Quality Management System.
• Works closely with the Quality Management team for all Quality‑related matters including complaints procedures.
• Provides support to the sales team and supply chain management for tenders and customer requests.
• Leads or supports RAQA projects and assignments as required.

To be successful you will need to meet the following:

• Bachelor's Degree in Pharmacy.
• 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, organised, and decisive.
• Applicants should be available for face‑to‑face interviews in the location mentioned above.