About UsLeica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.
Our mission of Advancing Cancer Diagnostics, Improving Lives is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.
The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers.
The company is headquartered in Nussloch, Germany. Visit for more information.
Position Summary and Overview of RA Officer role
This is a professional position with responsibilities for supporting tasks associated with the site regulatory obligations.
Will follow existing policies, procedures and work instructions to plan and conduct tasks. Will receive instruction and guidance from manager(s) or Sr.
RA Officer / Specialist(s). The entry level RA Officer / Specialist will minimally have a college or university degree in science (or equivalent), and the ability perform routine tasks.
With additional experience, the RA Officer / Specialist will work more independently and expected to apply experience to more complex tasks and problems.
o Support the review and analysis of product complaints, clinical reports and other data against established processes and procedures.
o Support and organize safety and filing decisions for in collaboration with Sr. RA Officer(s), RA management.
o Support and organize the review and approval of labeling, advertising and promotion for compliance to applicable regulations
o Support Sr. RA Officer(s), RA management in the implementation of new regulations.
o Work with global colleagues in support of product registrations and submissions.
o Establish and maintain official site regulatory files according to government expectations and company procedures
o Serve as site RA representative on new product development teams and change management initiatives
o Establish and maintain device listings and licenses according to government requirements
o Support the documentation of regulatory strategies
Required Skills / Experience / Education
Relevant certifications preferred.
o Experience with regulatory submissions and registrations
o Experience with regulatory affairs
o Experience with regulatory compliance
To Apply : Leica Biosystems is committed to attracting and retaining the most highly qualified candidates available. We firmly believe that our employees drive the success of the company.
With success in mind as the ultimate goal, we strive to create and provide an environment that offers challenging, stimulating and financially rewarding opportunities.
As a Leica Biosystems employee you will be consistently challenged to deliver your best. If you are ready for this challenge, submit your resume for consideration.
Be sure to follow Leica Biosystems on LinkedIn!Danaher Corporation OverviewDanaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide.
Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions.
Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage.
We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries.
We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders.