Senior Associate – Global Regulatory Affairs & Quality

Proclinical Staffing; Sydney; Hybrid; AUD 115,000 - 125,000; Full time

Benefits offered by this job

Hybrid flexibility

Strong team culture

Impact on patient outcomes

Job summary

A global medical device manufacturer in Sydney is seeking a Senior Associate for Regulatory Affairs & Quality to manage post-market operations. The role requires 5+ years in a similar field, focusing on compliance and collaboration across functions. Excellent problem-solving and communication skills are essential, and a degree in Life Sciences or Engineering is preferred. Join this purpose-driven organization and make a tangible impact on patient outcomes.

Qualifications

• Minimum 5 years' experience in quality and regulatory affairs within the medical device sector.
• Strong understanding of ISO 13485, TGA, FDA, and quality systems principles.

Responsibilities

• Manage global post-market activities including complaint handling and reporting.
• Develop centralized post-market surveillance process.
• Liaise with internal and external stakeholders globally.

Skills

Quality and Regulatory Affairs

Complaint Handling

Post-market Surveillance

Data Analysis

Communication Skills

Education

Degree in Life Sciences or Engineering

Tools

eQMS Platforms

Job description

Senior Associate – Global Regulatory Affairs & Quality

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.

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 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 [e-mail] for a confidential discussion.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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