Quality Specialist (Medical)

What is this opportunity?

Key Responsibilities Regulatory Affairs: Ensure compliance with applicable medical device regulations (e.g., 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 lab…

Opportunity details