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 at Radiometer is responsible for delivering on the regulatory life cycle management and supporting different projects related to Radiometer products with Blood Gas. You will have the opportunity to work with a wide range of products with regulatory and technical complexity in a truly global organization.
This position is part of the Quality and Regulatory Affairs located in Bronshoj, Denmark and will be a hybrid position with a possibility to work from home two days a week At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
You will be a part of the RA Blood Gas Team and report to the Director responsible for Regulatory Affairs. If you thrive in an independent role and want to work to build a world-class RA organization—read on.
Roles and responsibilities
- Provides regulatory input and technical guidance on global regulatory requirements to product-development teams
- Works with supporting multiple projects
- Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategies (if appropriate) for changes that do not require submissions.
- Builds technical knowledge about Radiometer products
- Work with RA change assessment of impact for In-Vitro Diagnostics and Medical Devices across countries and regulations.
- Participate in Product projects both in new developments and in life cycle management.
- Translate and implement Regulatory knowledge to Radiometer products.
- Approval of Marketing material, Labels and ECOs
- Strategy and planning of projects and submissions for product in EU, US, CHN
- EU, US or CHN responsibility for product Writing submissions for 1-2 of the countries. Communicate with authority (with oversight)
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The essential requirements of the job include:
- The preferred candidate holds a master’s degree in science, Engineering, Pharmacy, Biology, Biochemistry or the like
- 5+ years of related work experience in Regulatory Affairs and/or directly supporting functions.
- Regulatory compliance experience
- Detailed knowledge/understanding of regulatory requirements for medical devices
- Experience with In vitro diagnostics will be preferred
- Detailed knowledge of EU MDD/MDR/IVD/IVDR requirements
- Detailed knowledge of CLSI guidelines and FDA relevant guidance documents
- Proven success interacting with regulatory agency personnel
- Experience in working with clinical and R&D projects
- Successful experience taking a product from development through to global regulatory approval
- Experience working as engineer
- Promotional item and labeling approval experience
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. If you have questions you can reach out to the hiring manager Noopur Gupta (noopur.gupta@radiometer.dk)
We thank you for your interest. Please read our Applicant Data Privacy Notice carefully here.
Danaher
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
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.
If you’ve ever wondered what’s within you, there’s no better time to find out.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
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.
If you’ve ever wondered what’s within you, there’s no better time to find out.
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