Regulatory Affairs Analyst II

Wondering what’s within Beckman Coulter? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges!

The Regulatory Affairs Analyst II for Beckman Coulter Diagnostics is an individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for post-market activities. Primary responsibilities include evaluation, coordination, preparation and implementation of post-market regulatory activities including: field actions (recalls), supporting international registrations, and design change evaluations. Additionally, this position supports regulatory strategy for new product development activities and applicable submissions or registrations.

This position is in the Immunoassay Regulatory Affairs team and reports to the Manager of Regulatory Affairs in Chaska, MN. It is responsible for managing regulatory initiatives and working with third parties as appropriate. The role builds consensus while championing global regulatory initiatives for projects. The role will be on-site three days per week, and the other two can work from home.

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:

• Create and manage Technical Files in compliance with IVDR regulations. 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 and work 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.
• Function as a stop-ship subject matter expert for new product registrations and field actions.

The essential requirements of the job include:

• Bachelor's Degree with 2 years of experience in Life Sciences/engineering or a Master's degree with 1 Years of experience in Life Sciences/engineering or Doctorate with 0-1 years of experience in Life Sciences/engineering.
• Subject matter expertise in the registration and commercialization of medical devices

This is also a plus:

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

Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.