Senior Quality and Regulatory Affairs Specialist

Benefits
• Opportunity to work within a global team.
• WFH flexibility (3 days from home and 2 days onsite).
• Competitive Salary package.
• Opportunity to collaborate with other internal and external stakeholders.
• Free parking available onsite.
• Continuous improvement and development of skillset and knowledge.


About the company
This organization is a renowned worldwide supplier of medical and scientific products, with a strong presence in the Australian market, they are situated in the Lower North Shore of Sydney. Their dedication to innovation is evident through their cutting-edge scientific equipment, which plays a pivotal role in researching and developing new treatments.


About the opportunity
The Senior Quality and Regulatory Specialist position is dedicated to the ongoing upkeep and enhancement of the QMS System, as well as ensuring compliance with regulations for all products. You will form part of the QRA team, and you will report directly to the Quality and Regulatory Affairs Manager ANZ. To excel in this role, you should possess impeccable attention to detail, self-management abilities, exceptional communication skills when interacting with internal and external stakeholders, excellent technical writing skills, and a flexible yet proactive approach when managing tasks.


Duties
• Managing and leading the internal audit schedule in ANZ for ISO9001 and ISO13485.
• Assisting with product registration documentation, tenders, and change notifications.
• Supporting with post-market reporting in ANZ such as, preparing, initiating, reporting recall action and adverse event to the TGA and MedSafe.
• Applying for and managing the different licenses and permits necessary for the organization.
• Answering any quality or regulatory queries from the local, regional, or global stakeholders.
• Regularly informing stakeholders about any necessary regulatory or legal updates and ensuring their proper implementation and maintenance.


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


Skills and Experience
• Tertiary University degree in a Scientific or Medical field.
• Minimum 5 years of local hybrid QA/RA experience within the medical device and IVD industries.
• Prior experience liaising with TGA and Med Safe.
• Knowledge of ISO13485 and ISO9001.
• Experience in leading ISO13485/ISO 9001 audits.
• Ability to multi-task and prioritize important tasks.
• Excellent verbal and written communication skills

Culture
At this company, they embrace the principles of equality, diversity, and inclusivity. The team is characterized by their friendliness and unwavering support for one another. The believe in the power of collaborating with different departments to achieve both individual and company-wide goals.

How to Apply
Click apply or send your resume to Tamara El Husseini, on telhusseini@hpgconnect.com to organize a confidential discussion.