QA Professional, Vigilance

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 QA Professional, Vigilance for Radiometer is responsible ensuring timely reporting of Adverse Events and supporting Field Actions globally and participating in or driving process improvements via the Danaher Business System (DBS).

This position is part of Global RA/QA located in Copenhagen, Brønshøj and will be a hybrid setup. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Vigilance Team and report to the Senior Manager of Vigilance responsible for timely reporting of Adverse Events, supporting Field Actions globally and engage in process improvements via the Danaher Business System (DBS). If you thrive in an impact-driven role and want to work to build a world-class Vigilance organization that improves patient care — read on.

In this role, you will have the opportunity to:

• Take responsibility for ensuring timely reporting of Adverse Events and Field Actions globally.
• Collaborate with a team of five highly skilled and engaged colleagues to facilitate, train, and communicate with organizational partners to seek solutions.
• Stay up to date on vigilance related legislation and implement this in Radiometer.
• Navigate fast-paced case handling with shifting priorities, tight deadlines, and thorough authority communication.

The essential requirements of the job include:

• Experience with vigilance/pharmacovigilance or other relevant communication with regulatory authorities.
• Knowledge of applicable standards and regulatory requirements in USA, Canada, Asia, Europe and other key markets (FDA, ISO, MDR, IVDR and MDSAP).
• Experience with working in databases.
• The preferred Candidate is fluent in English both in writing and verbally.
• The preferred candidate holds a master’s degree in engineering, Pharmacy, Biology, Biochemistry, or similar.

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

• Experienced MS Office (Excel, PowerPoint, Word, and Outlook), Mastercontrol, Miro user and also familiar working in databases (e.g. DocuNote).
• Strong communication skills and a can-do attitude

Application:
We continuously assess candidates and invite for interviews, so please don’t hesitate to submit your CV/resume and cover letter. If you have questions, feel free to contact Senior Manager, Vigilance Kristina Olsson on [email protected]. Thank you for your interest.

Danaher

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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Placering
Bronshoj, Denmark, state: , cityCountry: Bronshoj, Denmark