Regulatory Affairs Officer – Medical Association – Gauteng NEW

About the Job:

Seeking a Regulatory Affairs Officer to lead its regulatory affairs portfolio, represent the industry on key regulatory platforms, support governance structures, drive advocacy initiatives, and provide regulatory guidance to member

Requirements:

Bachelor’s degree in Pharmacy, Biomedical Engineering, Regulatory Affairs, Health Sciences, Law, Public Policy, or a related field

Minimum 5 years’ experience in medical device and/or IVD regulatory affairs

Strong knowledge of medical device and IVD regulatory frameworks and processes

Proven stakeholder engagement, project management, research, and communication skills

Advanced Microsoft Office proficiency, particularly Excel, and experience managing databases

Ability to work independently, manage multiple priorities, and meet deadlines

Analytical thinking and problem-solving

Strong communication and stakeholder management

Attention to detail and professional judgement

Project management, adaptability, and resilience

Duties & Responsibilities:

Regulatory Leadership & Representation

Represent the Medical Association on medical device and IVD regulatory matters across key industry and regulatory forums

Build and maintain relationships with regulators, policymakers, industry bodies, and other stakeholders

Communicate industry positions and regulatory updates through presentations, forums, and stakeholder engagements

Regulatory Governance & Committee Support

Provide secretariat and governance support to the Regulatory Committee, including meeting coordination, documentation, minutes, and action tracking

Support committee planning, KPI monitoring, ratifications, and reporting requirements

Prepare regular regulatory updates and reports for the Executive Officer and Board

Regulatory Intelligence & Advocacy

Monitor, analyse, and communicate local and international regulatory developments

Research regulatory best practices and contribute to industry advocacy positions

Draft and coordinate regulatory submissions, position papers, and responses to policy and legislative developments

Provide regulatory guidance and support to members and stakeholders

Stakeholder Engagement & Communications

Manage regulatory forums, stakeholder databases, distribution lists, and communication platforms

Maintain regulatory website content and contribute to member communications, publications, and events

Support the development and delivery of regulatory presentations, training, and awareness initiatives

Budget & Service Provider Management

Develop and manage the annual regulatory budget

Monitor expenditure and ensure effective use of resources

Appoint, negotiate with, and manage external consultants and service providers

Should you meet the above requirements, we urge you to apply by forwarding your CV along with any supporting documents to info@glass-house.co.za