Senior Specialist, QARC

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Leica Biosystems one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Leica Biosystems were not just shaping the future of cancer diagnostics were transforming lives. Our mission of Advancing Cancer Diagnostics Improving Lives is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis we empower clinicians with innovative reliable solutions so they can give patients timely accurate answers when they need them most. When you join Leica Biosystems youre not just taking a job; youre becoming part of a passionate team that knows every moment matters when it comes to cancer. Youll help develop diagnostic solutions that turn anxiety into answers and aid the acceleration of next-generation life-changing therapies. Surrounded by a diverse and collaborative global community youll be inspired each day to stretch grow and make an impact.

Learn about the Danaher Business System which makes everything possible.

The Senior Specialist QARC role is accountable for ensuring organizations compliance status against applicable quality processes regulatory requirements and harmonised standards is continually understood monitored and communicated. Where compliance gaps are identified the Senior Specialist develops and drives appropriate remediation plans to ensure timely and effective resolution.

This on-site role is based in Melbourne and reports to the Director II Quality Assurance and Regulatory Compliance

In this role you will have the opportunity to:

• Perform IVD Product registrations (Class 1/11/111 under IVDR Class A/B/C and Companion Diagnostic devices) with local governments in time and in accordance with global product launch schedule and local launch plans.

• Make technical documentation available for inspection by the TGA as provided by legal manufacturers. Ensure maintenance of licenses and complete on time license renewals as required.
• Ensure correct labeling UDI and other related requirements as supplied to the region are in compliance with local regulation prior to placing the product on the market in SAP for import.
• Plan registration strategies and create action plans and timelines with SU and legal manufacturers for product change implementation new product launches and market expansion activities.
• Ensure processes remain compliant related to product import warehousing labeling and delivery to ensure sustained quality of products sold.

The essential requirements of the job include:

• Bachelors degree in science engineering biomedical medical technology or a related technical field.
• Minimum 5 years experience in Quality Assurance and/or regulatory affairs in a regulated environment preferably medical device or vitro diagnostics.
• Working knowledge of ISO 13485 risk management audits CAPA nonconformance and document control.

Travel Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel occasionally with travel expectations for this role being low (less than 10%).

It would be a plus if you also possess previous experience in:

• Experience supporting both Regulatory and Quality Assurance responsibilities within a highly regulated manufacturing environment.
• Experience in medical device or in vitro diagnostics environments.

Leica Biosystems a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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