Quality and Regulatory Affairs Manager

1 week ago

Brisbane, Australia Queensland Health Full time

We are Metro South Health
We are the major public healthcare provider for Brisbane's south side, Logan, Redlands and the Scenic Rim. We operate five major hospitals and a range of community, specialty and state-wide healthcare services. We are renowned for teaching and research excellence.
We are truly dedicated people who care about our community. We come to work to make a difference. We save lives, changes lives and make the world a better place. We overcome the many challenges that come our way by going above and beyond and achieve the best possible outcomes by working together. We are bold, innovative, collaborative, inspiring.
We recognise our strength comes from the diversity of our people and so we encourage people of all genders, ethnicities, ages, abilities, languages, sexual orientation and family responsibilities to apply.
We are committed to creating a diverse and inclusive workplace for our people and our community.
We are part of and proud of the community we serve. We are better together.
Join us at Metro South Health and be part of a world-class, dynamic and growing health service that embraces technology, excellence in health care, teaching, research and empowering our people to be the best in serving our community.
About the Role
The primary purpose of the Quality and Regulatory Manager is to support all compliance activities within this surgical support department which will require adherence to, and maintenance of, ISO13485 medical device quality management as well as Good Clinical Practice for clinical trial investigations. In addition to ongoing ISO 13485 certification audit requirements, the Quality and Regulatory Manager will also be responsible for preparing updated ARTG listings in alignment with TGA guidance on Class II PMD with the support and input from other clinical and staff as well as external regulatory experts.
About You
We are looking for people from all backgrounds to ensure our hospital reflects the diversity of our community.
- Lead the preparation and development of procedures and protocols that support new and ongoing TGA listings to manufacture and supply medical devices (Class I to III).
- A passion for creating positive change in patient outcomes.
- The ability to work collaboratively within a multidisciplinary team.
- A commitment to excellence in everything you do.
- The capacity to balance workload to ensure timely patient care.

Our values of Integrity, Compassion, Accountability, Respect, Engagement and Excellence, shape our culture within Metro South Health. Our values guide our day-to-day decision making and are fundamental to what we care about as a health service, how we behave, how we interact with each other and provide care to the many patients who come through our doors every day.
We offer rewarding career opportunities across a wide range of clinical and non-clinical areas across our health service and pride ourselves on providing a work environment that is safe, satisfying, flexible, and promotes a healthy work-life balance.
As a Metro South employee, you will benefit from a higher than standard employer contribution to Superannuation of up to 12.75%, access to salary packaging, flexible working arrangements and competitive salary rates with annual incremental increases.

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