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Radiometer

Regulatory Affairs Professional

Posted on Nov. 19, 2024

  • Turku, Finland
  • 0 - 0 USD (yearly)
  • Full Time

Regulatory Affairs Professional

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The Regulatory Affairs, Professional for Radiometer is 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.

This position is part of the Regulatory Affairs Department located in Finland and Denmark and will be on-site in Finland. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Global Commercial Regulatory and Quality team and report to the Director, Global Commercial RAQA responsible results of the RA organization, including compliance, audit preparation and completeness, and growth initiatives such as registrations and submissions around the globe. If you thrive in a multifunctional, leadership, fast paced, supporting role and want to work to build a world-class Regulatory Affairs organization—read on.

In this role, you will have the opportunity to:

  • International registration by compiling of dossiers to obtain approvals worldwide
  • Input of country data in the RA database
  • Maintain market approvals and current documents within your responsibility area

The essential requirements of the job include:

  • Master Degree in Science, Engineering, Pharmacy, Biology, Biochemistry or the like.
  • Experience with the medical device and/or in-vitro diagnostic legislation.
  • Experienced in working with registration or other regulatory aspects of Medical Devices
  • Fluent in english

It would be a plus if you also possess previous experience in:

  • Experienced in communication with regulatory authorities.
  • Experience in working independently and ability to deliver within tight deadlines

Application

We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. The recruitment will be completed as soon as suitable candidate is found.

We look forward to seeing your application.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.


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