Quality Assurance and Regulatory Affairs Specialist

Benefits
• 5 days on-site
• Opportunity to work within a global medical device organization.
• Opportunity to collaborate with local and global stakeholders.
• Competitive salary package.
• Career progression opportunities.


About the company
This organization is a leading global provider of innovative medical aesthetic devices located in the Lower North Shore of Sydney. They hold a strong focus on research and development, and specialize in advanced technologies, with a diverse product portfolio. This company is committed to delivering effective and safe solutions for enhancing the aesthetic appearance of patients, working closely with healthcare professionals worldwide.

 
About the opportunity
As the Quality and Regulatory Specialist ANZ, you will serve as the primary point of contact for all quality processes and any quality related issues with the 3PL. As well as, managing promotional materials, maintaining current and new licenses, and submitting applications to regulatory bodies ensuring compliance with company policies and regulatory requirements. In this role, you will report directly to the Quality and Regulatory Manager APAC. To excel in this position, you must possess the ability to work independently as well as collaboratively within a team. You should demonstrate excellent organizational and strategic planning skills, exceptional communication abilities, and an adaptable approach to project management.
 
 
Duties

• Maintain and implement new process improvements to the QMS system.
• Overseeing quality release, labelling, complaints investigations, change control, NCRs, and CAPA.
• Managing the local QC testing with external laboratories when required.
• Preparing the audit schedule and leading internal and external audits.
• Continuously maintaining product registration and ensuring compliance to regulatory requirements.
• Managing variation submissions, product registration renewal, and approval for any product changes.
• Ensuring all labels and documents are up-to-date and comply with regulatory requirements.
• Regularly liaising with internal, external, and global stakeholders.

 
**Please note, the ideal candidate has unrestricted working rights in Australia
 
 
Skills and Experience

• Tertiary University degree in a Scientific or Medical field.
• Minimum 4 years of local QA/RA experience within the medical device or pharmaceutical industry.
• Knowledge of ISO9001, GDP, and GMP.
• Experience with QMS Systems and Microsoft Office
• Excellent verbal and written communication skills
• Ability to work autonomously, prioritize important tasks and planning.

 
Culture
With its global reach, this company prioritizes fostering collaboration, support, and a friendly atmosphere within the team.
 
How to Apply
Click apply or send your resume to Tamara El Husseini / Gemma Staddon, on telhusseini@hpgconnect.com or gstaddon@hpgconnect.com to organize a confidential discussion.