AddressResonance 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:
- Ensuring the compliance of ISO 13485, IEC 62304, and Regulatory requirements for medical devices and maintaining records in compliance with relevant standards.
- Preparation of Technical Documents such as DMRs, IFUs, Risk Management files etc.
- Maintaining the Quality Management System in accordance with ISO13485-Medical Devices and FDA 21 CFR 820.
- Assisting with ISO certifications and maintenance of the Quality Management System in relation to regulatory changes and risk management.
- Reviewing and signing-off on the release of products.
- Assisting with audits and ensuring the completion of any related actions resulting from audits.
- Initiating, investigating and following up CAPAs, NCCRs and NCRs as required and ensure the effectiveness of actions taken.
- Preparing QA and RA documentation, including SOPs, WIs and Forms.
- Reviewing and updating risk requirements and Device Risk files.
- Review and development of Post Market Surveillance Plans and management activities.
- Regulatory assessment of product changes and supporting regulatory audits and recalls. This requires interaction and communication with internal business units and external regulatory agencies.
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:
- Nine-day fortnight flexible work option, in addition to other flexible working arrangements.
- A permanent position in a growing company with an exciting vision.
- Our office overlooks a park in Burswood with parking, great public transport, and end of trip facilities.
- A wide range of yummy snacks provided in the office to keep you fueled up.
- A friendly and happy team environment, working with talented and smart people.
- Floating Public Holidays, so that you can substitute any Public Holiday for another day of your choice.
- Market competitive remuneration.
- We promote internally and focus on the development of our employee.
