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Regulatory Affairs Specialist, Marketing and Scientific Claims Expert in Brønshøj, Denmark at Radiometer

Date Posted: 2/24/2019

Job Snapshot

Job Description

Job ID: MED001681

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

In Radiometers RA/QA department, we are Partnering for Impact towards the organization. Radiometer develops advanced medical devices designed to help caregivers make diagnostic decisions that save lives. 

You are curios to learn how we empower caregivers to use these medical devices and comply with all applicable product marketing, advertising and promotion laws and regulations worldwide. You want our customers to get a balanced communication and that claims are scientifically well founded. We currently have a cross-functional project running where you as the RA participant in the project will use your competences to improve the process for approval of sales and marketing material.

Combine your scientific background with your communication skills
Together with other departments in our head quarter (marketing, sales, legal, clinical & medical affairs) and our subsidiaries, we are responsible for ensuring that the project generated documentation demonstrates compliance with labelling and promotion requirements in the markets where we sell our products. 

Regulatory Affairs in Radiometer consists of 6 teams and is a dynamic worldwide team with employees in Denmark, Finland, Russia, India, US and China. You will have the possibility for learning and growth in this role. 

Key Responsibilities 
• Ensure training and implementation of new processes in RA
• Support compliant marketing material worldwide
• Translate legislation and ensure implementation
• Drive and participate in process improvements

By handling these responsibilities with on-time delivery, you ensure compliance and our license to operate. The job does not require a lot of travelling, but some days during the year must be expected. 

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. The atmosphere in RA is very positive and we focus on our good relations in the team and with our stakeholders cross-functionally. 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 Wednesday 20 February 2019. 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.

If you see that you fit the requirements and need further information, please contact Senior Director, Regulatory Affairs, Gitte Friis at tel. +45 21 69 32 80.

Job Requirements



Qualifications

The preferred candidate holds a Master’s Degree in Engineering, Pharmacy, Medical, Biology, Biochemistry or the like. This combined with most of the following increases your chances of success in the job: 

• Good communication skills
• Has experience with review of marketing material from an RA perspective
• Experience with process improvement 
• Preferably, experience with the medical device legislation (IVD, MD) on different markets
• Preferably, experience with work relations in different cultures
• The preferred Candidate is fluent in English both in writing and verbally
• Experienced with the use of MS Office (Excel, PowerPoint, Word, and Outlook) user and familiar working in databases and with Adobe Acrobat Pro.



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.