Regulatory Affairs Specialist

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 RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

This position is part of the Global Regulatory Affairs department located in Brønshøj, Denmark and will be Hybrid position. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Blood Gas Regulatory Affairs team and report to the Hsiao-Qing Chow, Director, RA responsible for the team that supports new product development RA and ensuring the market access is maintained in the major markets (EU, China & US).

If you thrive in a fast-paced environment, is used to playing a critical supporting and coordinating role and want to work to build a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.

In this role, you will have the opportunity to:

  • Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
  • Ensure compliance with EU regulations.
  • Generate STED files, international submissions & assess design changes.
  • Plan and execute projects for new regulatory requirements.

The essential requirements of the job include:

  • Master’s degree, e.g., engineering, biotechnology, pharmaceutical sciences, medical technology, or similar science field
  • At least 3 years’ experience in Regulatory Affairs within In vitro Diagnostic Devices or medical devices
  • Experience writing regulatory submissions for EU, US, or China
  • Experience with cross-functional work
  • Experience with cross-cultural collaboration

Hybrid

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

Application

We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application.

We thank you for your interest. Please read our Applicant Data Privacy Notice carefully here.

Part of Danaher Corporation

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, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

This is who we are and the essence of why we come to work every day. It’s a sneak peek into our world.
Welcome to Radiometer.

Follow us

Working at Radiometer

Helping health care professionals put life first

While every day half a million blood samples are tested around the world using Radiometer equipment, we are not the heroes.

The heroes are the health care professionals who face constant change and challenging situations. And, we are proud to help them ensure life comes first through connected solutions, expert knowledge and trusted partnership.

After all, no one knows what comes next, but in Radiometer, answering what’s next in health care starts with what comes first - life.

Better together

The uniqueness of our team members is key for our ability to grow our business and continue to understand and support an increasingly diverse customer base.

Currently, our team comprise 68 different nationalities speaking 63 different languages. Their unique perspectives are the reason we can continue to meet customer needs and bring new and innovative solutions to market.

‘Best team wins’ is our mantra and a strong competitive differentiator for us. It applies to both the way we work in our teams and the way we work with our customers.

About Radiometer - We save lives for a living

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 here

Radiometer Medical ApS | Åkandevej 21 | DK-2700 | Brønshøj | Denmark | Phone +45 38 27 38 27

Follow us