In-Demand Regulatory affairs specialist Jobs

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Senior Specialist, QARC

Leica Biosystems -
Mount Waverley VIC

Apply Now

Job Details

Full-time
4 days ago

Benefits

Annual leave

Qualifications

SAP
Engineering
Quality assurance
Bachelor's degree
Risk management
Manufacturing

Full Job Description

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 Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re 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, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll 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, you’ll 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 organization’s 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:

Bachelor’s 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 it’s 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, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.

Apply Now

Refine Your Search

regulatory affairs specialist jobs

Senior Specialist, QARC

Regulatory Lead : Post Market

Compliance Lead (Origin Zero)

Director - Government Affairs

Consultant / Senior Consultant, Company and Personal Insolvency

Senior Marketing Specialist

Manager Communications and Engagement

Government Industry Development Manager

Senior Legal Counsel Claims

Technical Documentation Specialist (Medical Devices & ISO 13485)

Lead Speechwriter

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