Medical Device Regulatory & Quality Specialist

Staff Solutions; Cape Town; On-site; ZAR 600,000 - 900,000; Full time

Job summary

Staff Solutions in South Africa seeks a Regulatory Affairs professional to lead regulatory compliance, product registrations, and quality processes for medical devices. You will collaborate with cross-functional teams to ensure market access and adherence to standards.

Responsibilities cover registration submissions, document control, audits, and continuous improvement aligned with ISO 13485, ISO 14971, EU MDR, FDA, and SAHPRA requirements.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Quality Management, Life Sciences, Engineering, or related field.
• 3–5 years’ experience in regulatory, compliance, or HSE role within medical device, pharmaceutical, or healthcare industry.
• Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, EU MDR, FDA, SAHPRA, etc.).

Responsibilities

• Ensure compliance with medical device regulations (SAHPRA, FDA, EU MDR, ISO 13485, ISO 14971).
• Prepare, submit, and maintain product registrations, licenses, and approvals with regulatory authorities.
• Monitor regulatory changes and advise management on potential impact to business and products.
• Support audits and inspections by regulatory authorities and notified bodies.
• Maintain technical documentation, regulatory files, and product labelling compliance.
• Manage end-to-end registration of new and existing medical devices with SAHPRA and other authorities.
• Compile, review, and submit complete product registration dossiers (technical, clinical, quality, labeling, admin).
• Coordinate registrations renewals, variations, and change notifications within timelines.
• Liaise with authorities, manufacturers, suppliers, and representatives to resolve queries.
• Maintain an accurate product registration database, submission tracker, and approval records.
• Assess changes to determine regulatory impact and required submissions.
• Monitor registration timelines and provide status updates and escalation reports.
• Work cross-functionally with Quality, Sales, Marketing, Supply Chain, and international teams for launches and market access.
• Manage annual price increase process for registered products across funders, including pricing schedules and documentation.

Skills

Regulatory knowledge

Quality management

Compliance

Audits & inspections

Documentation control

Education

Bachelor in Regulatory Affairs/Quality Management/Life Sciences/Engineering

Job description

Staff Solutions in South Africa seeks a Regulatory Affairs professional to lead regulatory compliance, product registrations, and quality processes for medical devices. You will collaborate with cross-functional teams to ensure market access and adherence to standards.

Responsibilities cover registration submissions, document control, audits, and continuous improvement aligned with ISO 13485, ISO 14971, EU MDR, FDA, and SAHPRA requirements.