$75,000 - 85,000 yearly
Number of Applicants
:000+
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Resonance Health Ltd is an ASX listed Medical Technology and Services Company. We provide radiology-image analysis services for clients globally, using regulatory approved software (software as medical devices). Our image data analysis is used by doctors and clinicians for the diagnosis and management of patients. One of our products, FerriScan, has been available for over fifteen years and is globally recognised as the gold standard in the measurement of liver iron overload. In addition, Resonance Health provides services to pharmaceutical and therapeutic companies for their clinical trials.
Resonance is committed to delivering high quality services to the international medical community, and are seeking like-minded people to join our team.
About the Role:
Our Quality Assurance and Regulatory Department ensures that we take a rigorous approach to all we do, whilst ensuring that we understand and meet the regulatory requirements of the global markets we operate within.
We are seeking someone with experience within the medical device development or pharmaceutical industry and with some regulatory approval knowledge to join our team. We are open to meeting candidates with a range of skill and experience level, and believe that someone with the right values and team fit is as important as having someone with the right capability.
About the Role:
This is a broad role reporting into the GM Quality Assurance and Regulatory Affairs and working in a small, high performing team. Primarily this role is responsible for technical document preparation, authorising the release of products and conducting internal audits to monitor the ongoing effectiveness of the quality management system. Additionally, this role assists with the preparation and submission of new/renewals for new and existing regulatory applications. Other accountabilities and responsibilities of this role include:
About You:
You will have a formal qualification in either science or engineering, together with at least one (1) year of experience in quality management systems relating to medical devices. We are open to candidates with significantly more experience as well, and will tailor the role to suit.Experience or exposure to QMS accredited to ISO 13485 and ISO 9001 is required. Experience in GMP within Medical Devices or a related field is desirable.
You will have an excellent work ethic whilst enjoying connecting with a small, growing team. Your written and oral English skills will be a credit to you, and they will be important to your success in this role. You will be organised and able to prioritise, whilst having a high level of attention to detail and accuracy.
What we offer you:
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