Job Description

Senior Associate – Global Regulatory Affairs & Quality

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Senior 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.

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Base pay range

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A$115,000.00/yr - A$125,000.00/yr

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Direct message the job poster from Proclinical Staffing

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Life Sciences Recruitment Consultant - GxP Quality Assurance & Technical at Proclinical Staffing

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About the Company

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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.

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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.

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About the Role

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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.

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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.

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Key Responsibilities

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- Manage global post-market activities including complaint handling, vigilance reporting, and coordination of investigations with offshore manufacturing.
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- Develop and implement a centralised post-market surveillance process, including migration into a current eQMS system.
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- Analyse and trend post-market data to support continuous improvement and risk mitigation initiatives.
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- Liaise with internal and external stakeholders globally to ensure alignment and quality communication.
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- Support internal and external audits, staff training, and development of controlled quality documentation.
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- Contribute to the development and maintenance of global procedures and metrics.
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About You

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- Minimum 5 years' experience in quality and regulatory affairs within the medical device sector.
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- Proven experience managing post-market surveillance, complaint handling, and vigilance reporting.
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- Strong understanding of ISO 13485, TGA, FDA, MDR and quality systems principles.
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- Demonstrated ability to work cross-functionally across regions (e.g. Operations, R&D;, Sales & Marketing).
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- Hands-on experience with eQMS platforms highly regarded.
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- Excellent problem-solving, communication, and data analysis skills.
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- Degree in Life Sciences, Engineering or related discipline (equivalent experience considered).
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Why Apply?

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- Be part of a purpose-driven, growing global medtech company.
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- Work cross-functionally and make tangible impact on patient outcomes.
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- Hybrid flexibility and strong team culture.
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- Convenient Sydney-based head office.
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How to Apply

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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.

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Seniority level

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Mid-Senior level

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Employment type

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Full-time

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Job function

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Quality Assurance

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Industries

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Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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📌 Senior Associate - Global Regulatory Affairs & Quality (New South Wales)
🏢 Proclinical Staffing
📍 New South Wales