Danaher Corporation RA Officer in Newcastle, United Kingdom
Danaher Company Description
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. VisitLeicaBiosystems.com for more information.
Position Summary and Overview of RA Officer role 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 manager(s) or Sr. RA Officer/Specialist(s). The entry level RA Officer / Specialist will minimally have a college or university degree in science (or equivalent), and the ability perform routine tasks. With additional experience, the RA Officer/Specialist will work more independently and expected to apply experience to more complex tasks and problems.
• Conduct tasks that support one or more areas of the site regulatory responsibilities. May include tasks in the following areas:
• Adverse events and patient safety (MDR, Vigilance, clinical trials)
o Support the review and analysis of product complaints, clinical reports and other data against established processes and procedures.
o Support and organize safety and filing decisions for in collaboration with Sr. RA Officer(s), RA management.
o Support and organize the review and approval of labeling, advertising and promotion for compliance to applicable regulations
o Support Sr. RA Officer(s), RA management in the implementation of new regulations.
• Submissions, registrations, device listings, site licenses
o Work with global colleagues in support of product registrations and submissions.
o Establish and maintain official site regulatory files according to government expectations and company procedures o Serve as site RA representative on new product development teams and change management initiatives o Establish and maintain device listings and licenses according to government requirements o Support the documentation of regulatory strategies • Utilize knowledge and experience to identify and solve problems within the regulatory area. • Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function. • Serve as a resource to support senior staff including Senior RA Officer/Specialist(s). • Establish and maintain strong relationships with RA colleagues and wider QRA team. • Maintain working knowledge of relevant regulations and requirements that affect the business. • Other duties as assigned by management.
Required Skills/Experience/Education • Bachelor’s degree in science, medical or technical field and experience in medical device Regulatory Affairs • Graduate or advanced degree preferred • Experience in the IVD field preferred experience very beneficial • Must have requisite training or certification in medical device Regulatory Affairs through on-the-job training, seminars, training. 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 identify and assess patient and 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, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.
Organization: Leica Biosystems
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-United Kingdom-Tyne & Wear-Newcastle
Req ID: ADV000892