Senior Associate – Global Regulatory Affairs & Quality Senior Associate – Global Regulatory Affairs & Quality Get AI-powered advice on this job and more exclusive features. This range is provided by Proclinical Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range A$115,000.00/yr
- A$125,000.00/yr Direct message the job poster from Proclinical Staffing Life Sciences Recruitment Consultant
- GxP Quality Assurance & Technical at Proclinical Staffing

About the Company
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 chance 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.

About the Role
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 robust team culture.
- Convenient Sydney-based head office.

How to Apply
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 [email protected] for a confidential discussion. Seniority level




- Seniority level Mid-Senior level Employment type
- Employment type Full time Job function
- Job function Quality Assurance
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📌 Senior Associate – Global Regulatory Affairs (Sydney)
🏢 Proclinical Staffing
📍 Sydney