Manager Regulatory Affairs

Wondering what's within Beckman Coulter?

Take a closer look.

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.

xperience is preferred

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.