Senior Associate – Global Regulatory Affairs

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 - Gx P 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 e QMS 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 e QMS 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 level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Proclinical Staffing by 2x Get notified about new Senior Quality Assurance Specialist jobs in Sydney, New South Wales, Australia.
Sydney, New South Wales, Australia 3 weeks ago Kogarah, New South Wales, Australia 2 weeks ago Junior Legal Assistant - Corporate Commercial Sydney, New South Wales, Australia 1 day ago Sydney, New South Wales, Australia 2 days ago Sydney, New South Wales, Australia 2 weeks ago Sydney, New South Wales, Australia 2 days ago Sydney, New South Wales, Australia 1 day ago Sydney, New South Wales, Australia 3 weeks ago Sydney, New South Wales, Australia 4 months ago Sydney, New South Wales, Australia A$90,000.00-A$100,000.00 3 weeks ago Legal Assistant – Dispute Resolution & Litigation Sydney, New South Wales, Australia 3 weeks ago Corporate Governance and Advisory Paralegal Millers Point, New South Wales, Australia 1 week ago Sydney, New South Wales, Australia 1 day ago Sydney, New South Wales, Australia 2 weeks ago Sydney, New South Wales, Australia A$65,000.00-A$90,000.00 3 weeks ago Liverpool, New South Wales, Australia 1 day ago Hurstville, New South Wales, Australia 2 weeks ago Sydney, New South Wales, Australia 2 weeks ago Sydney, New South Wales, Australia 1 day ago Sydney, New South Wales, Australia 2 weeks ago Sydney, New South Wales, Australia 3 days ago Chatswood, New South Wales, Australia 3 weeks ago Corporate Associate | AM Law 50 Firm | New York Sydney, New South Wales, Australia 2 days ago We're unlocking community knowledge in a new way.
Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr

---