Senior Specialist, Quality Assurance and Regulatory Compliance

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, Quality Assurance and Regulatory Compliance (QARC) is responsible for leading and coordinating global field action management across Leica Biosystems, including recalls, corrections, removals, Field Safety Corrective Actions (FSCAs), customer notifications and related post-market activities. As the global field action process owner and subject matter expert, you will drive consistent, compliant and effective execution across regions while supporting inspection readiness and continuous improvement. This position reports to the Director II, Global Quality Management Programs and is part of the Global Quality Organization, located in Newcastle, UK, and will be an on-site role. In this role, you will have the opportunity to: Lead and coordinate global field actions from initial assessment through implementation, effectiveness verification and closure, ensuring compliance with applicable regulatory requirements and internal procedures. Serve as the global field action process owner and subject matter expert, maintaining global procedures and supporting alignment with EU IVDR, UK, FDA, Health Canada and ISO 13485 requirements. Partner with Quality, Regulatory, Operations and Commercial teams to assess and escalate potential field actions, including investigations, risk assessments, vigilance and reportability assessments. Coordinate field action strategy and execution, including regulatory notifications, customer communications, effectiveness checks, affected-product reconciliation and closure, escalating compliance risks or delays where required. Lead global field action governance, inspection readiness and continuous improvement through KPI monitoring, trend and ageing reviews, audit and inspection support, training and cross-regional best-practice sharing. The essential requirements of the job include: Bachelor’s degree in a scientific, medical or technical field. Demonstrated experience directly managing field actions, including recalls, Field Safety Corrective Actions (FSCAs), corrections or removals within the medical device or IVD industry. Experience in quality assurance, regulatory compliance, technical quality or post-market activities within the medical device or IVD industry. Demonstrated knowledge of applicable medical device and IVD post-market requirements, including EU IVDR, UK, FDA and Health Canada requirements and ISO 13485. Experience interacting with competent authorities, notified bodies, regulatory agencies or inspectors and leading cross-functional activities across multiple regions. Travel and Working Environment Requirements: Travel expectations for this role are low (<10%). Overnight travel may be required. The global nature of the role requires flexibility in working hours to collaborate across time zones, including participation in meetings outside standard local working hours as needed. It would be a plus if you also possess previous experience in: Proven experience discovering and meeting the needs of customers (either internal or external) Managing field actions across multiple regions and regulatory jurisdictions. #LI-Onsite 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.