Manager Quality Assurance & Regulatory Affairs in Arras, France at Beckman Coulter Diagnostics

Date Posted: 2/8/2018

Job Snapshot

Job Description

Job ID: BEC008812

About Us

Beckman Coulter develops, manufactures and markets
products that simplify, automate and innovate complex biomedical testing. Our
diagnostic systems are found in hospitals and other critical care settings
around the world and 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. Hospital laboratories are our core
clinical diagnostic customers. 



Description

Job Description: Manager – Quality Assurance & Regulatory Affairs


Date: 06th November 2017

About Us
Normand Info based in Arras (62 - France), has been operating for more than 30 years and has positioned itself as a software publisher specialized on Software products developments in the market of laboratory instruments.
Normand Info is organizationally part of Beckman Coulter which 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 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.

Summary of Role

Reporting to the ‘Senior Manager, Quality Systems WITS, the ‘Manager – Quality Assurance & Regulatory Affairs’ will lead Quality Assurance & Regulatory Affairs in accordance with Beckman WITS QMS.
Although office based at the Arras site the role includes travel as needed, estimated at 10 -20%.

Specific Responsibilities

• Continually develop Normand quality systems and infrastructure to ensure compliance, effectiveness and continual improvement
• Maintain and continually improve the quality processes needed to ensure compliance, effectiveness, and continual improvement
• Continually develop, monitor and report on the metrics needed to gauge the performance of the Quality Management System
• Establish and drive successful fulfillment of Normand quality system objectives; monitor and report on progress to these objectives.
• Support the establishment and fulfillment of WITS operations objectives
• Sustain and continually improve the Normand ISO 13485 Management System – manage the relationship with the Certification Body
• Liaise with the regional and global RA organization to support Normand site and Normand Products registration process
• Ensure implementation of Beckman escalation processes related to Customer Complaints with probable extensions to Medical Device Reporting / Adverse Events and/or Field Safety Corrective Actions
• Support the application of DBS tools throughout Normand operations and drive DBS activity within the Normand quality organization

Job Requirements



Qualifications

Person Spec – Minimum Requirements

• University Degree in Science or equivalent
• Fluent in English – written and verbal
• Skilled at managing ambiguity, influencing without authority and driving for results
• Experience of working within a global, multi-cultural, matrix organisation
• Experience of working in MedTech with solid understanding of the associated regulations 7 norms such as IVDD/IVDR, ISO 13485, FDA 21 CFR 820, ISO 14971 etc.
• Solid working knowledge of Regulatory Affairs
• Deep and current knowledge of Quality Management principles

Danaher Corporation Overview

At Danaher, you’ll have the opportunity to build a career in a way no
other company or environment can duplicate. We’re innovative, fast-paced,
results-oriented, and most importantly, like to win. Why? Because it’s fun!
But, when it comes to the development of our leaders and associates, we’re
serious. Our business is growing, and we need top talented people to keep
winning. The breadth and depth of our family of brands makes it possible for us
to offer a variety of dynamic and challenging career opportunities across
multiple global industries. Working with us, you’ll have the unique experience
to learn the Danaher Business System, our common operating system used to shape
strategy, focus execution, align our people, and create tremendous value for
customers and shareholders. At Danaher, great people do extraordinary
things.  Come join our winning team.