Regulatory Affairs & Quality Compliance Specialist

About the role

Solventum is seeking a Regulatory Affairs & Quality Compliance Specialist to act as Deputy Responsible Pharmacist and quality management representative for its South African and Sub‑Saharan operations. The role ensures that all products meet local regulatory and quality standards while supporting business growth across the region.

Key responsibilities

• Secure and maintain all applicable regulatory licences and certificates, including annual renewals, amendments, and rebranding.
• Prepare and submit timely regulatory filings, ensuring the validity of licences throughout their lifecycle.
• Monitor the regulatory landscape in real time, tracking legislative changes via internal systems and authority websites.
• Lead regulatory projects that enable product registration, listing, and market entry.
• Identify technical and regulatory opportunities and propose innovative solutions.
• Support the maintenance of Solventum SA’s ISO 13485:2016 certification.

Required profile

• Qualified pharmacist with experience in regulatory affairs and quality management.
• Familiarity with South African and Sub‑Saharan regulatory requirements for medical devices or healthcare products.
• Proven ability to manage multiple regulatory projects and meet strict deadlines.
• Strong analytical skills to interpret regulatory changes and assess impact.

Required skills

• Knowledge of ISO 13485:2016 standards.