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Danaher Corporation Staff Regulatory Affairs Specialist IV in Chaska, Minnesota

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!

The Regulatory Affairs Specialist IV for Beckman Diagnostics is a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre-market activities and managing complex issues that may have significant impact on the business.

This position is part of Regulatory Affairs and will be located in Chaska, MN.

You will be a part of the Immunoassay team and report to the Senior Manager of Regulatory Affairs. You will be responsible for managing global regulatory initiatives, working with third parties as appropriate. As a collaborative facilitator, you’ll build consensus while championing global regulatory initiatives for projects. You’ll also provide pre-market regulatory initiatives for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory strategies provide a competitive edge to Beckman Coulter.

If you thrive in a fast-paced role and want to contribute to a world-class Regulatory Affairs organization—read on.

In this role, you will have the opportunity to:

  • Author global pre-market submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market strategies.

  • Create / Manage Technical Files in compliance with IVDD and IVDR. Work with international colleagues on establishing design dossiers for their intended market.

  • Collaborate with international Regulatory Affairs professionals to support global product registrations. Using knowledge of global regulatory requirements achieve strategies that focus on speed to market and successful submissions to obtain approval in an efficient timely manner.

  • Collaborate with and ensure business teams consider the impact of current or emerging regulatory issues, works with Global Regulatory Affairs and other regulatory colleagues to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.

  • Ensure sound pre-market product regulatory strategies including minimizing the risk of negative pre-market submission actions, such as agency review delays.

The essential requirements of the job include

  • Bachelor's Degree with 9+ years of experience in Life Sciences or a Master's Degree with 7+ Years of experience in Life Sciences or Doctorate with 4+ years of experience in Life Sciences

  • Subject matter expertise in registration and commercialization of medical devices

  • Demonstrated experience developing effective pre-market regulatory strategies

It would be a plus if you also possess previous experience in:

  • Demonstrated knowledge and understanding of regulations and guidelines governing in-vitro diagnostics.

  • RAC certificate

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.

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.

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