Regulatory Affairs Specialist in Clare, Ireland at Beckman Coulter Diagnostics

Date Posted: 9/10/2019

Job Snapshot

Job Description

Job ID: BEC015946

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.
Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


Description

Title:   Regulatory Affairs Specialist
Career Band  P1/P2 Depending on Experience
Department:  Regulatory Affairs
Location:  Clare


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


•  RA representative on Design Change projects.
• 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 labelling.
• 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.
• Support, where required, in Global RA tasks / projects, which may include supporting RA colleagues outside of BCII.

Job Requirements



Qualifications

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 1+ 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 product registrations is desirable.


Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.