Remote Global Regulatory Affairs Lead – Medical Devices

Placements24; Mossel Bay; Híbrido; ZAR 1.000.000 - 1.800.000; Jornada completa

Descripción de la vacante

Placements24 is seeking a highly experienced Regulatory Affairs Manager for a fully remote role within South Africa. You will lead regulatory strategies for medical devices across SAHPRA, FDA, and CE markets.

The position requires strong leadership, excellent communication, and the ability to manage multiple complex projects from a remote setting. A dynamic team awaits those who can drive compliance and timely market access.

Formación

• Bachelor’s degree in a scientific or technical field; Master’s preferred.
• Minimum 7 years in regulatory affairs for medical devices.
• Proven track record with submissions/approvals in SAHPRA, FDA, and EU CE marking.
• Strong leadership, communication and project management skills.

Responsabilidades

• Develop and execute global regulatory strategies for medical devices.
• Prepare and manage regulatory filings and dossiers for SA, US, and EU markets.
• Ensure compliance with MDR/IVDR, FDA QSR and ISO 13485.
• Liaise with regulatory authorities and respond to inquiries.
• Lead and mentor a remote team of regulatory professionals.
• Monitor regulatory changes and assess impact on products.

Conocimientos

Regulatory strategy

Leadership

Regulatory submissions

Communication

Remote team management

Quality management systems

Regulatory information management

Educación

Bachelor’s degree in a scientific/engineering/technical field

Master’s degree or higher

Herramientas

Regulatory information management systems

Descripción del empleo

Placements24 is seeking a highly experienced Regulatory Affairs Manager for a fully remote role within South Africa. You will lead regulatory strategies for medical devices across SAHPRA, FDA, and CE markets.

The position requires strong leadership, excellent communication, and the ability to manage multiple complex projects from a remote setting. A dynamic team awaits those who can drive compliance and timely market access.