AddressIn this Quality Assurance Associate role that can be worked remotely, you will partner with areas of business to ensure Stryker South Pacific (SSP) follows all Post-Market activities in accordance with Quality System, regulatory and corporate requirements.
Responsibilities:
- Build relationships and liaise with key stakeholders from regulatory, operations, marketing and sales teams
- Action complaint handling product holds and product fields
- Ensure SSP process reflect all corporate and regulatory requirements
- Prepare and release regular reports associated with regulatory actions, and Post Market Surveillance
- Develop quality systems that are contemporary with industry business best practices
- Identify areas for process improvement and work with key stakeholder both locally and globally to implement actions accordingly.
Skills & Experience:
- 3+ years’ experience in the Health Industry in Regulatory Affairs and/or quality systems and standards such as ISO 9001 and ISO13485
- Proven experience in post market activity
- Proven ability to use initiative and drive to achieve results
- Natural talent to influence and build relationships across an organisation
- Knowledge and understanding of applicable external regulatory standards, including TGA, ISO 13485, FDA 820, AS/NZS3551
- Highly developed communication skills and experience working with a diverse range of internal and external customers and clients
Culture & Benefits
- Join one of Australia’s (and the world’s) Best Places to Work since 2014!
- Grow and develop your Regulatory Affairs career with a company that prides ourselves on personal and professional development
- Free on-site gym and parking!
To join us, click apply now!
Stryker is in the medical industry and the safety of our employees and communities is very important. To that end, it is a requirement that our employees be vaccinated, and it’s an inherent requirement for the successful candidate for this role to be vaccinated.
