Job description

Wondering what’s within Beckman Coulter Diagnostics? 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 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 located in Ireland and will be a hybrid position (on-site & remote). 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 EU & 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:
Stay up-to-date with, interpret, document and implement new and evolving regulatory requirements as they apply to the countries and regions of interest.
Represent European and METAM Regulatory Affairs in key internal projects.
Provide training on regulatory topics and procedures to the different business functions as needed.

Pre-Market Regulatory
Support global product registration initiatives and planning to enable access to new markets and drive growth for assigned product line(s).
Facilitate participation in tenders and customs clearance through the provision of regulatory documents such as statements, Safety Data Sheets, Declarations of Conformity, Certificates of Free Sale, Certificate to Foreign Government, etc.

Post-Market Regulatory
Execute the vigilance processes in Europe 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.
Support the implementation of Field Actions in countries outside of Europe.

The essential requirements of the job include:
A Degree/Diploma in Regulatory Affairs, Sciences or Life Sciences
Experience within the highly regulated in vitro diagnostic and/or medical device market for a minimum of 2 years
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, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.

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