Regulatory Affairs Specialist International Registration And Ivd Medical Devices Ledige Stillinger på Danaher Brønshøj
- Regulatory Affairs Specialist International Registration And Ivd Medical Devices
- Brønshøj D84
- Er åbningsdato
- 08 Feb, 2018 14 days ago
Danaher Brønshøj presserende behov efter position for Regulatory Affairs Specialist International Registration And Ivd Medical Devices. Læs denne jobannonce grundigt før ansøger om jobbet. Der er nogle kvalifikationer, erfaringer og kvalifikationsbehov, at arbejdsgiverne kræver. Er din karriere historie passer disse krav? Sørg for at du forstår den rolle, du søger, og at det er egnet til dine evner og kvalifikationer.
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Regulatory Affairs Specialist International Registration And Ivd Medical Devices Ledige Stillinger på Danaher Brønshøj Detaljer Job:
DANAHER COMPANY DESCRIPTION
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.
If you enjoy being outgoing and influencing big decisions then this job is your chance to use your experience related to RA, international registration and md and ivd medical devices and propel your development and career even further. The available position is an addition to the team and an acknowledgement of the important contribution that you can provide in our RA team.
Partnering the business for impact In Radiometer’s RA/QA department, we are Partnering for impact because this gives us a competitive advantage for reliable, fast and easy patient diagnoses. You join us at an excellent time as we have just launched the 2018 strategy and you get to be part of it and the many interesting tasks and projects that comes with the strategy. You joinMette Skytte Harpsøe’steam of 10 dedicated RA Specialists. Mette explains about the team:
“We are a very dedicated and well-functioning team. Our working environment and visual management boards encourage teamwork and helping each other reach our targets and deadlines. We enjoy each other’s company and like to celebrate our successes when we get a new product registered or complete an FDA inspection.”
- Your responsibility * With more than 1,100 colleagues on site you can look forward to an exciting collaborative environment where your cross-functional cooperation involves local RA, QA, R&D, Production and Sales and Marketing to name a few. Your responsibilities include: •International registration by compiling of dossiers to obtain approvals worldwide •Legislation monitoring and being able to translate this and implement this in Radiometer •Maintain Market approvals and current documents within responsibility area •Support to cross-functional projects •Participate in process improvements and creation of SOPs in the RA area
- 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.
The preferred candidate holds a Master Degree in Science, Engineering, Pharmacy, Biology, Biochemistry or the like. Your chances of success in the job are increased if you have the following experiences:
- Experience with the MD and /or IVD legislation •Proven track record of compiling regulatory files and achieving approvals worldwide. •Experience with work relations in different cultures. •Knowledge of international regulatory legislation. •Experience with RA support to cross-functional projects.
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.
JOB FUNCTION: Quality and Regulatory Affairs
PRIMARY LOCATION: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
REQ ID: MED001446