Regulatory Affairs Analyst EU & METAM

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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 for Beckman Coulter Diagnostics is responsible for the execution of pre and post market regulatory activities in support of the organization’s commercial objectives.

This position is part of the EU & METAM Regulatory Affairs department and will be a remote position. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the EU & METAM Regulatory Affairs team and report to the METAM Regulatory Affairs Manager responsible for ensuring compliance with regulatory imperatives in the region. If you thrive in a fast-paced multifunctional support role and want to work to build a world-class regulatory affairs organization—read on.

In this role, you will have the opportunity to:

• Support global product registration initiatives and associated regulatory activities to enable access to new markets and drive growth for assigned product line(s).

• Execute the vigilance processes including translations, notifications to authorities, timely distribution of customer letters, timely achievement of the required response rate and processing of related agency queries per company procedures.

• Represent European and METAM Regulatory Affairs in key internal projects.

• Stay up-to-date with, interpret, document and implement new and evolving regulatory requirements as they apply to the countries and regions of interest.

• Provide training on regulatory topics and procedures to the different business functions, as needed.

The essential requirements of the job include:

• A Degree/Diploma in Regulatory Affairs, Sciences or Life Sciences with 2 (two) years experience working in Regulatory Affairs

• Excellent English (written and oral)

• Proven Excel, Word and high level of IT literacy

• Attention to detail, rigorous, and ability to think critically and outside the box

• Ability to work autonomously and report effectively in an international environment

• Skilled at managing ambiguity, influencing without authority and driving for results

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

• Regulatory Affairs, specifically within the in-vitro Diagnostic Medical Device industry

• Managing regulatory projects from impact assessment to implementation

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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