Regulatory Affairs Specialist in Clare, Ireland at Beckman Coulter Diagnostics

Date Posted: 5/12/2018

Job Snapshot

Job Description

Job ID: BEC010271

About Us

At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.



We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.



Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences. 


Description

Title:                             Regulatory Affairs Specialist

Department:                 Regulatory Affairs

Location:                      Clare


Typical related responsibilities will include but are not limited to the following:



  • RA representative on IDP and Design Change projects.

  • Development and implementation of registration strategies for new product launches.

  • Preparation and submission of 510k for US clearance.

  • Preparation and maintenance of CE technical files in compliance with current IVDD and preparation for compliance to new IVDR.

  • Preparation and submission of dossiers and registration documentation for new product registrations and renewal of existing licenses.

  • Management of Field Action process for AU products.

  • Review and approval of device modification proposals.

  • Review and approval of all product labeling.

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

  • Participation in BCII Internal and External Quality Audit as required.

  • Participation in Management Reviews of the Quality & Environment System as required.

  • Communication to management on Regulatory affairs issues, which require addressing.

Job Requirements



Qualifications


  • addressing.

Education/ Experience:


  • Will be qualified to a minimum of B.Sc. level in a scientific field or other relevant technical field.

  • Have a minimum of 3 years’ experience in a QA or RA role within a manufacturing facility.

  • Excellent written and communication skills are essential, which will result in strong working relationships cross functionally within BCII

  • Ability to work in a very busy  environment,  ability to manage change effectively in order to better serve our internal customers, external customers and legislative demands.

  • Knowledge and understanding of the IVDD Directive and the associated harmonised standards.

  • Knowledge and understanding of ISO13485 and the FDA QSRs.

  • Experience of 510K preparation and product registrations is desirable.
Experience of design control assurance desirable

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.



At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.