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Danaher Corporation Staff Regulatory Affairs - Remote in Minneapolis, 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. Have the opportunity to build a meaningful career, be creative, and try new things with the support needed to be successful. Find the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) , which makes everything possible.

We hope you’ll see yourself here, too. What you find at Beckman Coulter — and within yourself — might just change the world!

The Staff Regulatory Affairs Specialist 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 in the Immunoassay Regulatory Affairs team and report to the Senior Manager of Regulatory Affairs in Chaska, MN or Remote.

This role is responsible for managing global regulatory initiatives, working with third parties as appropriate. Build consensus while championing global regulatory initiatives for projects. 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 and post-market strategies.

  • Create and manage Technical Files in compliance with IVDD and IVDR. Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.

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

  • Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, 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, including 510(k) to the FDA

  • Demonstrated experience developing effective pre-market regulatory strategies

This is also a plus:

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

  • RAC certificate

  • International experience with products in China or Europe

Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates’ lives. Whether it’s a health care program or paid time off, our programs add 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. As part of the Danaher's 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 about our associates on our Careers Blog (https://jobs.danaher.com/global/en/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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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