Wondering what’s within Danaher? Take a closer look.
At first glance, you’ll see Danaher’s scale. Our 67,000 associates work across the globe at more than 20 unique operating companies within four platforms—life sciences, diagnostics, water quality, and product identification. Look again and you’ll see the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. You’ll find the Danaher Business System, which makes everything possible. We are a company that investors trust—our culture of continuous improvement has helped us outperform the S&P 500 by more than 5,000% over the past 25 years.
And no matter where you look at Danaher, at the heart of what we do, witness our shared purpose—helping realize life’s potential—in action. Our work helps improve millions of lives.
We hope you’ll see yourself here, too. What you find at Danaher—and within yourself— might just change the world!
You will be a part of Beckman Coulter’s high performing Regulatory Affairs team and report to the Director of Regulatory Affairs in Miami, FL. Responsibilities include providing regulatory direction for New Product Development projects that will improve time to market globally. If you thrive in a fast-paced environment and want to work to build a world-class Regulatory Affairs organization—read on!
In this role, you will have the following opportunities, but are not limited to:
Support staff in managing workload within assigned projects through efficient resource utilization.
Oversee and ensure efficient processes for global registrations and post market compliance.
Liaison and negotiate with regulatory agencies and respond to inquiries. Determine the need and prepare documentation (e.g. Pre-Submissions, 510(k), STEDs, CDRH Laser Reports) and secure clearance and country approvals.
Ensure readiness for EU IVDR compliance.
The essential requirements of the job include:
Bachelor’s degree in Degree in Science, Engineering or Regulatory Affairs and 14+ years of experience, or Master’s/Doctoral degree and 12+ years of experience in a regulated medical device industry working with cross-functional product development teams. Experience will be considered in lieu of specific degrees.
4+ years supervisory and management experience.
Success negotiating complex premarket and post market regulatory strategies with FDA, NMPA and other regulatory agencies.
Experience authoring 510(k)s and product life cycle regulations, including change controls, design controls, risk management, along with knowledge of clinical study requirements and verification and validation activities.
It would be a plus if you also possess:
In Vitro Diagnostic experience
Professional designations are not required but training and relevant certifications would be a plus (e.g. RAC, CLIA, ASQ Certified Biomedical Auditor or Manager of Quality/Organizational Excellence)
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates’ and their families’ lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. We believe you’ll like what you see.
Beckman Coulter is a Danaher Operating Company. As a $20B company with 60,000 associates, ranked #162 on the Fortune 500 and, during the past 25 years, DHR stock has outperformed the S&P 500 Index by more than 5,000 percent. The strength of our results is a testament to our teams and the power of the Danaher Business System. Our Purpose: “Helping Realize Life’s Potential” is what makes us excited to come to work each day!
At Danaher, we’re driven by a sense of wonder for what we can create—and what we can become. Accelerate your career while driving innovation that improves lives. Work hard and take risks, with guidance from committed leaders, powerful DBS tools, and the support of a global organization.
If you’d like to learn more, read stories from our associates on our Careers Blog or reach out to one of our recruiters.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or email email@example.com to request accommodation.
Internal Number: R1135466
About Beckman Coulter Diagnostics
We are proud to be a part of Danaher. Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
Beckman Co...ulter 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.
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, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
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