The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. At first glance, you’ll see we are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Look again and you’ll see we are invested in you and you’ll have 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. You’ll also see 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 Beckman Coulter, at the heart of what we do, you’ll 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 Beckman Coulter —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 Sr. Manager of Regulatory Affairs in Chaska, MN. Responsibilities include providing regulatory direction for compliance and global registration projects that will ensure global market access for our portfolio of products. 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 9+ years of experience, or Master’s/Doctoral degree and 7+ 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.
2+ years supervisory and management experience.
Success negotiating complex post market regulatory strategies with FDA and other regulatory agencies.
Experience with product life cycle regulations, including change controls, design controls, risk management, and verification and validation activities.
It would be a plus if you also possess:
In Vitro Diagnostic experience
510(k) submission 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, a Danaher company, 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.
At Beckman Coulter, we’re driven by a sense of wonder for what we can create—and what we can become. Here, you’ll accelerate your career while driving innovation that improves lives. You’ll work hard and try new things, with guidance from committed leaders, powerful DBS tools, and the support of a global organization. As part of the Danaher family of 67,000 associates across the globe, your possibilities for growth and development are unparalleled.
We believe that creativity and innovation thrive when the most diverse set of voices are heard, and that’s why we’re taking concrete steps to ensure that we’re fostering an inclusive and engaging workplace for our team. If you’d like to learn more, read stories from our associates on our Careers Blog or contact 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.