At a Glance
- Tasks: Lead post-market quality and regulatory operations in a global medtech company.
- Company: Join an innovative global medical device manufacturer making a real difference.
- Benefits: Competitive salary, hybrid work options, and a strong team culture.
- Other info: Convenient Sydney-based office with excellent career growth opportunities.
- Why this job: Make a tangible impact on patient outcomes while growing your career.
- Qualifications: 5+ years in quality and regulatory affairs with a focus on medical devices.
The predicted salary is between 115000 - 125000 $ per year.
Proclinical is proud to be exclusively partnered with a growing and innovative global medical device manufacturer that is leading the way in delivering life-changing solutions for patients. This is a rare opportunity to join a purpose-driven organisation at a pivotal point in its growth journey as it transitions into a world-class, quality-led medical device company with a global footprint.
As Senior Associate – Global Regulatory Affairs & Quality, you’ll play a key role in post-market quality and regulatory operations, supporting compliance, continuous improvement, and robust product lifecycle management. Reporting directly to the Global Director – Regulatory & Quality, you will lead complaint handling and vigilance processes, develop post-market systems, and ensure alignment with ISO 13485, TGA, and international regulatory standards.
Key Responsibilities:
- Manage global post-market activities including complaint handling, vigilance reporting, and coordination of investigations with offshore manufacturing.
- Develop and implement a centralised post-market surveillance process, including migration into a new eQMS system.
- Analyse and trend post-market data to support continuous improvement and risk mitigation initiatives.
- Liaise with internal and external stakeholders globally to ensure alignment and quality communication.
- Support internal and external audits, staff training, and development of controlled quality documentation.
- Contribute to the development and maintenance of global procedures and metrics.
About You:
- Minimum 5 years' experience in quality and regulatory affairs within the medical device sector.
- Proven experience managing post-market surveillance, complaint handling, and vigilance reporting.
- Strong understanding of ISO 13485, TGA, FDA, MDR and quality systems principles.
- Demonstrated ability to work cross-functionally across regions (e.g. Operations, R&D, Sales & Marketing).
- Hands-on experience with eQMS platforms highly regarded.
- Excellent problem-solving, communication, and data analysis skills.
- Degree in Life Sciences, Engineering or related discipline (equivalent experience considered).
Why Apply?
- Be part of a purpose-driven, growing global medtech company.
- Work cross-functionally and make tangible impact on patient outcomes.
- Hybrid flexibility and strong team culture.
- Convenient Sydney-based head office.
If you’re ready to take the next step in your Regulatory & Quality career, click APPLY NOW or reach out to Pamela Phoumavong, Senior Consultant at Proclinical at 02 9054 7411 or p.phoumavong@proclinical.com for a confidential discussion.
Senior Associate – Global Regulatory Affairs & Quality in Sydney employer: Proclinical Staffing
Proclinical is an exceptional employer for those looking to make a meaningful impact in the medicinal cannabis industry. Located in Collie, WA, we foster a collaborative work culture that prioritises operational excellence and employee growth, offering comprehensive training and development opportunities. Our commitment to maintaining pharmaceutical-grade standards ensures that you will be part of a team dedicated to quality and compliance, all while enjoying the unique advantages of working in a fast-paced, innovative environment.
