- SalaryCompetitive Salary Package + Benefits
- LocationSydney
- Job type Full Time
- DisciplineQuality Assurance, Regulatory Affairs
- ReferenceBH-42032
Consultant
Back to jobs
RA/QA Specialist
Job description
Benefits
About the company
Our client is a global leader in the medical technology space, specialising in the design and manufacture of cutting-edge medical devices. With a strong presence in both national and international markets, they are renowned for their innovation and commitment to improving patient outcomes.
About the opportunity
This is a crucial role where you will manage and maintain the QMS ensuring compliance with local and international regulatory requirements. You will report to the Senior Manager and work closely with cross-functional teams across R&D, manufacturing, and operations. Your contribution will directly impact the company's ability to bring new products to market, ensuring patient safety and product quality.
Duties
Skills and Experience
Culture
Join a forward-thinking, innovative company that values teamwork, continuous improvement, and high standards of quality. Their collaborative culture fosters professional growth and supports work-life balance.
How to Apply
Click apply or contact Gemma Staddon, Specialist Manager, on gstaddon@hpgconnect.com.
About Healthcare Professionals Group
Healthcare Professionals Group recruits across all areas of healthcare – including Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care. For more job opportunities, visit www.hpgconnect.com.
- Competitive salary package with career development opportunities
- Flexible work arrangements promoting work-life balance
- Collaborative environment & broad role
About the company
Our client is a global leader in the medical technology space, specialising in the design and manufacture of cutting-edge medical devices. With a strong presence in both national and international markets, they are renowned for their innovation and commitment to improving patient outcomes.
About the opportunity
This is a crucial role where you will manage and maintain the QMS ensuring compliance with local and international regulatory requirements. You will report to the Senior Manager and work closely with cross-functional teams across R&D, manufacturing, and operations. Your contribution will directly impact the company's ability to bring new products to market, ensuring patient safety and product quality.
Duties
- Ensure compliance with ISO 13485 and other relevant regulations
- Oversee product registrations and regulatory submissions
- Conduct internal audits and manage CAPAs
- Support post-market surveillance and risk management activities
Skills and Experience
- Tertiary qualification in science or engineering
- Strong understanding of ISO 13485 and TGA/MDR
- Experience with product registrations and submissions
- Excellent communication and problem-solving skills
Culture
Join a forward-thinking, innovative company that values teamwork, continuous improvement, and high standards of quality. Their collaborative culture fosters professional growth and supports work-life balance.
How to Apply
Click apply or contact Gemma Staddon, Specialist Manager, on gstaddon@hpgconnect.com.
About Healthcare Professionals Group
Healthcare Professionals Group recruits across all areas of healthcare – including Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care. For more job opportunities, visit www.hpgconnect.com.