Job Description

Leica Biosystems\xe2\x80\x99 mission of \xe2\x80\x9cAdvancing Cancer Diagnostics, Improving Lives\xe2\x80\x9d is at the heart of our corporate culture. We\xe2\x80\x99re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you\xe2\x80\x99re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we\xe2\x80\x99re working at the pace of change to improve patient lives with diagnostic tools that address the world\xe2\x80\x99s biggest health challenges.The RAQA Specialist will prepare regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals. This individual will represent RA on project core teams, coordinate and prepare document packages for regulatory submissions from all areas of company as well as for internal audits and inspections. Compile all materials required in submissions, license renewal, and annual registrations. Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keep abreast of changes of new or updated regulatory policies and issued guidance.The RAQA specialist assists with the preparation of in country QMS documentation. This includes identifying and maintaining Warehouse SOP, incoming and outgoing inspections, in-country labelling requirements, if any. Support audits and PMS activitiesThis position is part of the Global regulatory affair, located in Singapore or Australia and will be remote, our vision is to advance cancer diagnostics and improve lives.You will be a part of the global registration team and report to the Senior RAQA Manager APAC responsible for North Asia (ANZ, HKTW) region. If you thrive in a multifunctional and fast paced role and want to work to build a world-class global regulatory affair organization\xe2\x80\x94read on.In this role, you will have the opportunity to:

• Work independently and on cross-functional teams preparing and submitting technical documentation, pre-market authorization applications, change notifications, renewals, and responses to regulatory bodies or channel partners.

• Collects, organizes, and maintains regulatory information and intelligence for in vitro diagnostic devices at local, regional, and global levels.
• Executes both pre-market and post-market regulatory activities, ensuring compliance with applicable regulations.
• Supports continuous improvement and accountability through the use of DBS tools and active participation in project teams.
• Establish and manage Leica\'s quality policies, oversee compliance processes (including warehouse tasks, distributor management, product returns, CAPA, and corrective actions), ensure regulatory reporting and audit readiness, and act as the Quality Management Representative (QMR), if required

The essential requirements of the job include:

• Bachelors\xe2\x80\x99 degree with 2+ years of relevant experience or a certificate in medical devices with 2 years of experience or 3+ years of experience in the medical devices or a related industry.
• Understands Regulatory Affairs concepts and is should be familiar with regulations/ guidelines governing development of diagnostic products
• Ability to prioritize, multi task, and organize work
• Ability to succeed in a fast-paced environment with capability to be flexible and adaptable to meet business need
• Well versed in MS office and applications

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

• Ability to perform in country IVD/MD submission with local Regulatory Authority (HKTW & ANZ)
• Support local Audits
• Certified in ISO 13485 or in country QMS regulation

At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.Join our winning team today. Together, we\xe2\x80\x99ll accelerate the real-life impact of tomorrow\xe2\x80\x99s 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 .At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Danaher