Regulatory Affairs Specialist II - 18 month FTC at Danaher - Canada

O'Callaghansmills, Killaloe Municipal District, Ireland -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

0.0

Posted On

28 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CAPA Management, Global Procedure Review, Product Registration, IVDR Document Maintenance, Design Change Management, Regulatory Submissions, Change Management, Regulatory Support, Stop Ship Program, Communication Skills

Industry

Medical Equipment Manufacturing

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 Specialist for Beckman Coulter Diagnostics is responsible for ensuring that the quality systems aspects such as CAPA management, global procedure review and participation in the cross-site Global Regulatory Affairs initiatives in addition to product registration, IVDR document maintenance and minor/moderate design change management for the AU Chemistry Product line. 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 and is an onsite position. 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 Regulatory Affairs Manager, be 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. This is a contract role for 18 months In this role, you will have the opportunity to: Act as RA representative on Design Change projects which includes the development and implementation of registration strategies. Prepare and submit product listing changes in the US Prepare and maintain 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 change management and perform RA support for minor and moderate design changes for the AU product line. 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. The essential requirements of the job include: Qualified to a minimum of B.Sc. Level in a Science related field with a minimum of 3 years’ experience in a QA or RA role within a manufacturing facility. 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. 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. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here.

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Responsibilities

The Regulatory Affairs Specialist is responsible for managing quality system aspects like CAPA, reviewing global procedures, and participating in global RA initiatives, alongside product registration and IVDR document maintenance for the AU Chemistry Product line. This role involves acting as an RA representative on design change projects, preparing US product listing changes, and maintaining EU technical files.