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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.
This is a professional position with responsibilities for elements of the site regulatory obligations. May include specialized responsibilities in Adverse Event reporting (MDR, Vigilance, HHE), communications with regulatory bodies, recalls and field actions, Post Market Surveillance and Complaints
In This Role, You Will Have The Opportunity To
* Process customer complaints through evaluation and investigation to closure, determine if they are reportable to Regulatory Authorities
* Generate Post
* market data for review and assist in the presentation of data to the appropriate teams
* Review and analyze product complaints, clinical reports and other data against established processes and procedures
* Make safety and filing decisions for routine matters. Collaborate with management and medical affairs for non-routine or serious events
The Essential Requirements Of The Job Include
* Bachelor's degree in science, medical or technical field and experience with increasing responsibility in medical device Regulatory Affairs
* Graduate or advanced degree preferred
* Experience in the IVD field preferred / experience very beneficial
* Must have requisite training or certification in medical device Regulatory Affairs through on-the job training, seminars, training
Travel, Motor Vehicle Record & Physical/Environment Requirements
Travel expectations for this role are low (
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.
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