Junior RA Specialist IVDR (12 Month FTC) in Newcastle upon Tyne, United Kingdom at Leica Biosystems

Date Posted: 10/4/2019

Job Snapshot

Job Description

Job ID: ADV001156

About Us

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.  Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com  for more information.


Position Summary and Overview

This is a professional position with responsibilities for supporting tasks associated with the site regulatory obligations. Will follow existing policies, procedures and work instructions to plan and conduct tasks.  Will receive instruction and guidance from Sr. RA Officer, RA Manager and Sr. QRA Manager. The entry level RA Specialist will minimally have a college or university degree in science (or equivalent), and the ability perform routine tasks.  With additional experience, the RA Specialist will work more independently and expected to apply experience to more complex tasks and problems.

Major Responsibilities

Conduct tasks that support one or more areas of the site regulatory responsibilities.  May include tasks in the following areas:

• Compliance to European IVD Regulation
o Support Sr. RA Officer(s)/Specialist(s), RA management in the implementation of the European IVD regulations.
o Review Design History Files to identify what information is required for the Technical Files
o Create Technical files compliant to European IVD Regulation
o Support the generation of Performance Evaluation Plans and Reports (excluding the Clinical Evidence sections).
o Create a process for updating/ maintaining Technical Files
o Support the generation of Quality Procedures and Work Instructions for the maintenance of Technical Files.
o Support the review and approval of labeling for compliance to applicable regulations

• Submissions and Registrations
o Support RA officer(s)/Manager with coordinating Technical File Reviews by the Notified Body.
o Support RA Officer/ Manager with information entered on to the Eudamed Database
o Support the documentation of regulatory strategies
o Coordinate documentation requested for registrations

• Site Support

o Utilize knowledge and experience to identify and solve problems within the regulatory area.
o Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function.
o Serve as a resource to support senior staff including Senior RA Officer/Specialist(s) in Post Market Surveillance reports.
o Establish and maintain strong relationships with RA colleagues and wider QRA team.
o Maintain working knowledge of relevant regulations and requirements that affect the business.
o Other duties as assigned by RA management.

Job Requirements


Required Skills/Experience/Education

• Bachelor’s degree in science, medical or technical field and experience in medical device or pharmaceutical Regulatory Affairs
• Graduate or advanced degree preferred
• Experience in the IVD field preferred experience very beneficial
• Training or certification in medical device Regulatory Affairs through on-the-job training, seminars, training preferred.   Relevant certifications preferred.
• Depending on assigned area:
o Experience with regulatory submissions and registrations
o Experience with regulatory affairs
o Experience with regulatory compliance


• Ability to apply practical RA experience and knowledge to one or more area(s) of regulatory affairs
• Ability to participate in the identification and assessment of patient/user risk
• Ability to work independently
• Strong organizational skills.  Ability to multitask
• Strong communication skills. Ability to explain difficult or sensitive information. Works to build consensus.  
• Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports. 
• High level of integrity

To Apply:
Leica Biosystems is committed to attracting and retaining the most highly qualified candidates available. We firmly believe that our employees drive the success of the company. With success in mind as the ultimate goal, we strive to create and provide an environment that offers challenging, stimulating and financially rewarding opportunities.  As a Leica Biosystems employee you will be consistently challenged to deliver your best. 
If you are ready for this challenge, submit your resume for consideration.  http://www.leicabiosystems.com/about/careers/
Be sure to follow Leica Biosystems on LinkedIn!

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, 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.