Regulatory Manager – Medical Devices

About the role

An established organisation operating in the healthcare and medical‑device sector is looking for an experienced Regulatory Manager to lead its Regulatory Affairs function. The role involves shaping regulatory strategy, ensuring compliance with South African and international requirements, and supporting market access for medical‑device products.

Key responsibilities

• Develop and implement a regulatory affairs strategy aligned with business growth and commercial objectives.
• Provide strategic regulatory guidance to senior management and other business functions.
• Oversee preparation, review and submission of regulatory applications, product registrations, amendments and renewals.
• Maintain up‑to‑date licences, permits and certifications, ensuring ongoing compliance.
• Monitor changes in legislation, assess impact on products and implement mitigation measures.
• Lead and mentor the Regulatory Affairs team, acting as primary liaison with SAHPRA, industry bodies and internal stakeholders.
• Manage technical documentation and quality‑management‑system records required for registrations.

Required profile

• Senior‑level professional with extensive hands‑on experience in medical‑device regulatory affairs.
• In‑depth knowledge of South African medical‑device regulations and SAHPRA requirements.
• Proven track record of successful product registrations and regulatory submissions.
• Experience with quality management systems and technical documentation.
• Strong leadership and strategic thinking abilities.

Required skills

• Regulatory affairs
• Medical device registration
• Quality management systems
• Technical documentation
• Regulatory submissions