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SAT was established to develop, manufacture and market cardiac-related medical devices that address the need of up to 75 million rheumatic heart disease patients worldwide. It is our mission to make lifesaving, cost-effective cardiac devices and deployment systems available to sufferers of heart disease in developing countries. Strait Access Technologies Holdings is looking for a highly competent, efficient, thorough, and hardworking Regulatory Affairs Specialist. The position requires the candidate to demonstrate initiative, be able to work independently and have strong interpersonal skills and time management, organizational and communication skills. This candidate will be an integral part of an interdisciplinary team of Scientists, Engineers, Clinicians and Technologist personnel in developing transcatheter heart valve replacements and deployment systems. The position will be effective as soon as reasonably practicable. Key responsibilities Identify, plan and coordinate training for SAT team members Technical Documentation and Reporting (SAHPRA, FDA, CE, ISO 13485) Product realisation in design and development according to ISO 13485 Compliance with medical device regulatory requirements. ● Tertiary degree as per the minimum requirements ● At least 2 years of experience in a similar role ● Ability to work independently and in a team ● Good communication skills (verbal and written) Market-competitive and experience influenced Apply Now

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Jobs in Go!