Regulatory Affairs & Quality Compliance Specialist

SOLVENTUM; Randburg; Híbrido; ZAR 600.000 - 950.000; Jornada completa

Descripción de la vacante

Solventum, the new healthcare company formed from the legacy of 3M Health Care, seeks a Regulatory Affairs and Quality Compliance Specialist in South Africa. You will secure regulatory licences, manage registrations, and monitor changes to ensure ongoing compliance across SA and Sub‑Saharan regions.

You will lead regulatory projects, support ISO 13485:2016 maintenance, audits, and improve processes while collaborating with global teams. Hybrid work and travel are involved in this role.

Formación

• Bachelor’s Degree or higher: Pharmacist
• Minimum 2 years’ experience in Medicines Registration experience
• Minimum 5 years’ experience in Quality Assurance
• Registered Pharmacist (with SAPC)

Responsabilidades

• Secure all applicable regulatory licences and certificates.
• Ensure timely regulatory submissions and maintain licences and certificates.
• Maintain real-time monitoring of regulatory landscape and changes.
• Lead regulatory projects to support business opportunities with timely registration/listing of products.
• Support audits and management of external partners and distribution centres.
• Report complaints and adverse events per internal systems and regulatory requirements.

Conocimientos

Medicines registration experience

Quality Assurance

Registered Pharmacist

Educación

Bachelor’s degree or higher: Pharmacist

Descripción del empleo

Solventum, the new healthcare company formed from the legacy of 3M Health Care, seeks a Regulatory Affairs and Quality Compliance Specialist in South Africa. You will secure regulatory licences, manage registrations, and monitor changes to ensure ongoing compliance across SA and Sub‑Saharan regions.

You will lead regulatory projects, support ISO 13485:2016 maintenance, audits, and improve processes while collaborating with global teams. Hybrid work and travel are involved in this role.