Global Medical Device Regulatory Leader

Placements24; Polokwane; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive compensation

Health insurance

Generous PTO

International travel opportunities

Professional development

Job summary

Placements24 is seeking an experienced Regulatory Affairs Manager to lead regulatory strategy for medical devices in Polokwane. You will develop submission plans, manage documentation, and liaise with regulators to ensure market access.

This is a leadership role with ownership of regulatory programs and team development. You will oversee global regulatory compliance across product lifecycles, coordinate submissions to SAHPRA, FDA and CE, and drive continuous improvement in regulatory processes.

Qualifications

• 6+ years of regulatory affairs experience in medical devices.
• Proven track record of submissions and approvals.
• Knowledge of MDR/IVDR/FDA regulations.
• Strong leadership and communication skills.

Responsibilities

• Develop and lead global regulatory strategies for devices.
• Prepare and submit dossiers to health authorities (SAHPRA, FDA, CE).
• Ensure product lifecycle compliance and post-market surveillance.
• Mentor and manage a regulatory team.
• Interpret regulatory changes and advise the business.

Skills

Regulatory leadership

Regulatory strategy

Project management

Regulatory submissions

Communication

Team mentoring

Education

Bachelor's degree in a scientific/technical field

Advanced degree preferred

Job description

Placements24 is seeking an experienced Regulatory Affairs Manager to lead regulatory strategy for medical devices in Polokwane. You will develop submission plans, manage documentation, and liaise with regulators to ensure market access.

This is a leadership role with ownership of regulatory programs and team development. You will oversee global regulatory compliance across product lifecycles, coordinate submissions to SAHPRA, FDA and CE, and drive continuous improvement in regulatory processes.