Senior Associate – Global Regulatory Affairs

Senior Associate – Global Regulatory Affairs & QualitySenior Associate – Global Regulatory Affairs & Quality

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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

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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 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.

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 strong 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 p.phoumavong@proclinical.com for a confidential discussion.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesMedical Equipment Manufacturing and Pharmaceutical Manufacturing

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