Job Description: Job ID: COR001111
Leica 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 LeicaBiosystems.com for more information.
Leica Biosystems Imaging, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.
Be sure to follow Leica Biosystems on LinkedIn!
This is a management position providing expertise and management of the Regulatory Affairs (RA) function for our cancer in vitro diagnostics business. Responsible for a broad spectrum of global regulatory needs, including premarket and post-market regulatory affairs to support Leica's growing business. The Manager will ensure RA deliverables are coordinated across multiple LBS global regulatory experts working in a highly matrixed environment.
Will serve as the site RA representative to regulators and Notified Bodies for routine matters
May include specialized responsibilities in adverse event reporting (MDR, Vigilance, HHE), registrations/submissions, regulatory intelligence, compliance, device listing, communications with regulatory bodies, recalls and field actions, advertising & promotion, regulatory support of new product development and device change processes
Experienced in multiple areas of medical device regulatory affairs and is capable of applying that experience and in-depth knowledge to work independently with minimal guidance from management
May lead small projects with manageable risks and resource requirements
Responsible for planning, organizing and conducting duties related to assigned areas of the site's regulatory obligations. May include one or more of the following areas:
o Review and approve labeling, advertising and promotion for compliance to applicable regulations
o Track the progress of new and updated regulations that impact the business (regulatory intelligence)
o Identify and implement new or updated regulations that are routine or do not have a major impact on the business
o In conjunction with management, develop plans to implement regulations that have a significant impact on the business (e.g. IVDR, UDI, Companion and Complementary Diagnostics)
o Participate and contribute to LBS or Danaher councils for regulatory intelligence and compliance
o Submissions, registrations, device listings, site licenses
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 Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function
Required Skills & Experience
Bachelor's degree in science, medical or technical field and 5+ years' experience with increasing responsibility in IVD/Medical Device Regulatory Affairs; graduate or advanced degree preferred
Direct Supervisory/Management experience of RA professionals
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; relevant certifications preferred
Travel expectations for this role are approximately 10-15%
Danaher Corporation Overview
Danaher 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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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. Come join our winning team.