Senior Analyst Regulatory Affairs

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 Senior Analyst Regulatory Affairs for Beckman Coulter Diagnostics is responsible for IDP project support, product registration globally, IVDR document maintenance and minor/moderate design change management for the AU Chemistry Product line. In addition, there will also be a responsibility to ensure that the quality systems aspects such as CAPA management, global procedure review and actions arising from the cross-site Global Regulatory Affairs Council (GRC) and Product Labelling Council (PLC) are supported.

This position is part of the Quality and Regulatory Affairs Department located in Beckman Coulter Ireland Inc., Lismeehan, O'Callaghan's Mills, Co. Clare, Ireland. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Regulatory Affairs team and report to the Senior Regulatory Affairs Manager responsible for providing regulatory support to local regulatory team on site, Beckman Coulter customers and Beckman Coulter’s commercial regulatory teams globally. If you thrive in a fast paced, challenging and supporting role in a company that is focused on sustainability and want to work to build a world-class Quality and Regulatory Affairs organization—read on.

In this role, you will have the opportunity to:

• Act as RA representative on IDP and Design Change projects which includes the development and implementation of registration strategies for new product launches including the preparation and submission of 510k for product launches in the US and the preparation and maintenance of technical files in compliance with IVD Directive and IVD regulation as applicable for the EU.

• Review, preparation and compilation of documentation required for global regulatory submissions.

• Support Global RA tasks/projects, which may include supporting RA colleagues outside of the Co. Clare site

• Control distribution of product from regulatory perspective through regulatory stop ship program.

• Participate in the weekly Global Regulatory Council (GRC) and Product Labelling Council (PLC) relaying any changes for assessment back to the Clare RA team / site for assessment.

• Support change management and perform RA support for minor and moderate design changes for the AU product line.

The essential requirements of the job include:

• A relevant third qualification (Level 8), e.g. Science related field with a minimum of 5 years’ experience in a QA or RA role within a manufacturing facility OR relevant Master's degree with 3 years relevant experience OR Doctoral degree

• Excellent written and communication skills

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

• Manage change effectively in order to better serve internal customers, external customers and legislative demands, in a busy environment, with demonstrated ability to multi-task

• Understanding of the ISO13485, ISO9001, CMDR, MDLW, ANVISA, TGA, IVDD, IVDR and FDA (including China) regulation requirements.

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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