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Danaher Corporation Regulatory Affairs Manager in O'Callaghan Mills, Ireland

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 Manager for Beckman Coulter Diagnostics is responsible for

  • Providing leadership in overseeing regulatory activities for products under the responsibility of Beckman Coulter Ireland Inc.

  • Providing leadership for regulatory activities related to new product development, design changes and compliance projects.

  • Managing resources and developing direct reports to include performance objective setting, development planning, frequent development discussions and formal annual appraisals.

This position is part of the Quality and Regulatory Affairs department located in Beckman Coulter Ireland Inc., Co. Clare and will be an on-site role (where on-site is defined as a minimum three 3 days on site). At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Quality and Regulatory Affairs team and report to the Senior Regulatory Affairs Manager. If you thrive in a leadership role in a fast-paced, global environment 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:

  • Oversee regulatory activities including product registrations/re-registrations globally, device modifications impacting registrations/licenses and market issues leading to Field Actions.

  • Select, develop and lead personnel in the Regulatory Affairs function at Beckman Coulter Ireland Inc.

  • Manage and provide resources for Design Change projects.

  • Assess the impact of global regulation changes on the registration of the AU product line globally.

  • Be involved in cross-functional projects contributing to problem solving and continuous improvement initiatives.

The essential requirements of the job include:

  • BSc in relevant scientific field with 9+ years’ related experience or MSc. / PhD in relevant field with 7+ years’ related experience.

  • Have 2+ years’ experience managing people.

  • Knowledge and understanding of the IVD Directive, IVD Regulation and associated harmonized standards, ISO13485 and the FDA QSRs.

  • Strong team leader.

  • Excellent written and communication skills.

  • Ability to work in a very busy environment and to manage change effectively.

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

  • Knowledge and understanding of 510K submissions, IVDR technical files and IVD product registrations in China.

  • Design Control experience and development of regulatory plans for projects.

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for an on-site work arrangement which is defined as being on-site a minimum of 3 days each week. The other 2 days can be on-site or remotely from your home. Additional information about this work arrangement will be provided by your interview team.

Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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.