Regulatory Affairs Associate

7 days ago

Ryde, Australia Pettit Pharma & Device Search Full time

Do you have Class III Device Application & Conformity Assessment experience?
- Be your best with unique resources & high-quality benefits
- Maquarie Park location, parking on-site, hybrid office & home work

THE COMPANY YOU WOULD BE JOINING
- Make a difference in the world at this medical device organisation with a global focus.
- Multi-national organisation, strong clinical focus with quality healthcare products, across multiple therapeutic areas.
- Very customer-centric with solid focus on excellent patient outcomes.

WHAT’S IN IT FOR YOU?
- At this organisation, their culture is critical to enabling their people to be the best they can be.
- It’s very important that all their employees are able to focus on making an impact on the world and feel empowered to bring innovation to their work.
- Be your best with unique resources and high-quality benefits, enhancing your life.
- Develop yourself through inspiring work by leading important projects, working with diverse, talented people and finding endless opportunities to develop your skills - while enjoying access to many perks, programs and resources.

THE JOB - ESSENTIAL FUNCTIONS PERFORMED - WHAT YOU WILL LEAD & GROW
- They have an exciting opportunity for a talented individual to join their team as a Regulatory Affairs Associate for Medical Devices - ANZ.
- Collaborate with cross-functional teams to compile and submit regulatory submissions for medical devices in accordance with local regulations and guidelines.
- Support the development and maintenance of regulatory documentation, including technical files, design dossiers, and quality management system records.
- Interact with regulatory authorities to address enquiries, provide necessary documentation, and resolve any compliance issues.
- Stay updated on industry trends, new regulations, and changes in the regulatory landscape, providing valuable insights to the team.
- Perform post market activities to support product compliance.
- Review artwork/packaging materials supporting compliance and registration of products.

WHO ARE WE LOOKING FOR?
- A bachelor degree in a relevant scientific or health discipline.
- Demonstrated experience in regulatory affairs within the medical device industry.
- Class III Device Application and Conformity Assessment experience.
- Solid understanding of regulatory frameworks, such as TGA and Medsafe.
- Strong knowledge of ISO 13485.
- Excellent written and verbal English communication skills, with the ability to communicate complex regulatory concepts effectively.
- Strong interpersonal skills, with the ability to collaborate and interact with teams both locally and internationally.
- Meticulous attention to detail and a keen eye for accuracy.
- Ability to prioritise in a dynamic environment.
- Full working rights for Australia.

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