Regulatory Affairs Position for Medical Device Engineer in Brønshøj, Denmark at Radiometer

Date Posted: 5/12/2018

Job Snapshot

Job Description

Job ID: MED001491

About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.

On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.


Want to know more about our mission and vision? Click on the link: Link of YouTube video




Our people

At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.


If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.


Description

Imagine opening a box full of technologically advanced medical devices designed to help caregivers make diagnostic decisions that save lives. You immediately feel the curiosity to learn more about the functions, designs and ideas behind these inventions. Now you can open that box and begin a professional journey in Radiometer Medical, a successful medical device company. This job is your opportunity to impact regulatory aspects and compliance related to the development and product life cycle of several medical devices.  

Combine your engineering background with quality mind-set
You have most likely always known that you would love to work with products like ours. Finally, the combination of complex technology for usage in the healthcare industry. Your future colleagues, many of who has been in Radiometer for several years, look forward to work with you because you are passionate and persistent. We need your ability to deliver quality on time and your thirst for knowledge ensuring that what you don’t know today, you will learn tomorrow. 

Your assignments
You might not have previous experience with all of the following assignments, but your engineering or science background preferably in mechanics or electronics, passion and drive enables you to work with: 
• Participating in R&D projects covering Regulatory issues
• Translating legislation and ensuring implementation
• Participating in process improvements and creation of SOPs (Standard Operating Procedures) in the regulatory area
• Supporting regulatory compliance related to change control processes and cost projects

Successful execution of these tasks depend on cross-functional cooperation with Quality Assurance, R&D, Production, Sales and Marketing and other departments. Together with our local sales companies, you and your new Regulatory Affairs team are responsible for preparing and compiling regulatory dossiers to ensure that their content is in accordance with internal and external guidelines and maintain current market approvals and documentation. 

Contribute, grow and develop 
Radiometer is a growing organization always developing through LEAN management tools and values. It makes it fun and meaningful to be part of an organization where your thoughts and ideas are embraced by management and can make a true impact. Developing on a personal and professional level is of a high importance for everyone in Radiometer and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher. 
Application deadline
Application deadline is Monday 7 May 2018. Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents, and bring diplomas if invited for an interview. We look forward to receiving your application.
For further information, please contact Gitte Juel Friis, Director, Regulatory Affairs, tel. +45 21 69 32 80

Job Requirements



Qualifications

Most importantly, you hold a Master’s Degree/Ph.D. in Engineering, Pharmacy, Medical, Biology, Biochemistry or the like combined with experience or valuable knowledge related to Medical Devices. Furthermore, we believe that most or some of the following increases your chance of success in the job:
• Knowledge or curiosity about medical device legislation (IVDD, MDD) on different markets.
• Experience with regulatory support or collaboration to cross-functional projects.
• Experience or skills enabling you to compile regulatory files and achieving approvals worldwide.
• Experience with work relations in different cultures.
• Confident and fluent communicator in English verbally and in writing.



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.