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The hearX Group offers the world's first clinical smartphone hearing test solutions. Our award-winning products are used in over 25 countries. Our aim is to impact on an individual, community and global level by creating sustainable, smart solutions for hearing health for everyone.
Job Purpose:
To assist with maintaining a company-wide quality management system (QMS) as well as assisting with medical device certification(s), including, but not limited to ISO13485, CE and FDA. This includes maintaining documentation of specifications and procedures, advising the internal team on regulatory and quality issues, and keeping up to date with the latest local and international standards. Ensuring registration and compliance with the relevant authorities/notified bodies.
Minimum education (essential):
Minimum education (desirable):
Qualified professionals
Risk Management
Essential Competencies:
Important Competencies:
Quality Management 40%
Regulatory Compliance 40%
Record - Keeping 20%
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