We are looking for a Regulatory Manager to lead and oversee the organisation's regulatory affairs function by developing and executing regulatory strategies that ensure compliance with applicable local and international regulations, facilitate market access, and support the successful commercialisation of medical devices.

Your:

Qualification:

Minimum: Postgraduate qualification in Regulatory Affairs, Quality Management, Medical Device Regulation, or a related field

Preffered: Extensive knowledge of the South African Health Products Regulatory Authority (SAHPRA) Medical Device Regulations.

Experience:

Minimum: 5 years' experience in a senior Regulatory Affairs role within the medical device industry, with extensive knowledge of medical device regulations, including product registrations, quality management systems, technical documentation regulatory submissions, and compliance with local and international regulatory requirements.

Will Enable you to:

1. Strategic Leadership & Direction

• Contribute to the development and execution of the organisation's strategic objectives by providing regulatory leadership.
• Develop and implement the regulatory affairs strategy aligned with business growth and commercial objectives.
• Executes the responsibilities according to lawful and ethical standards.

2. Regulatory Compliance

• Ensure organisational compliance with the South African Medical Device Regulations and all applicable regulatory legislation.
• Oversee the preparation, review and submission of regulatory applications, registrations, amendments and renewals.
• Maintain all required regulatory licences, permits and certifications.
• Monitor changes in legislation and regulatory requirements and implement appropriate compliance measures.
• Ensure regulatory documentation is maintained in accordance with quality and legal requirements.

3. Licensing & Stakeholder Management

• Oversee licensing and registration activities with relevant regulatory authorities, including SAHPRA, Department of Health (DoH), ICASA and other applicable bodies.
• Build and maintain strong strategic relationships with regulatory authorities, industry bodies and external stakeholders, including SAHPRA, SABS, DoH, ICASA, SAMED and other relevant organisations.
• Represent the organisation during regulatory inspections, audits and official engagements. Collaborate with internal business units to facilitate compliant and timely product launches.

4. Global Regulation

•  Stays abreast with global regulations, EU MDR, FDA, as well as the regulations of Sub-Saharan countries and all the jurisdictions approved by SAHPRA
• Communicate to colleagues the aspects of regulatory requirements and compliance ta be able to import, export, manufacture and distribution of medical devices.

4. Global Regulation

• Stays abreast with global regulations, EU MDR, FDA, as well as the regulations of Sub-Saharan countries and all the jurisdictions approved by SAHPRA.
• Communicate to colleagues the aspects of regulatory requirements and compliance ta be able to import, export, manufacture and distribution of medical devices.

6. People & Leadership

• Lead, develop and manage the Regulatory Affairs team to achieve departmental objectives.
• Establish departmental goals, KPIs and performance standards.
• Manage departmental budgets and resources effectively.
• Drive continuous improvement initiatives to optimise regulatory processes and operational efficiency.
• Foster a high-performance culture through coaching, mentoring and succession planning.

Contact information

Pieter