Senior Safety Advisor

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.

This position is based onsite at Radiometer’s headquarters in Brønshøj, Denmark, where you’ll be part of the Medical Safety team. You will join the Safety, Surveillance and Reporting department within the broader Clinical, Medical, Safety and Surveillance organization, and report directly to the Director of Safety, Surveillance and Reporting.

The Medical Safety team is responsible for the science and practice of professional medical activities pertaining to the detection, assessment, understanding and prevention of patient harms. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

So, if you thrive in a role utilizing your medical knowledge helping patients and want to work to support a world-class Medical Safety team—read on!

As a Senior Safety Advisor, your key responsibilities will be

• Developing and reviewing risk documentation, including benefit-risk assessments and hazard/harm analyses
• Preparing safety risk assessments and health hazard evaluations related to field actions
• Applying your expertise in managing adverse events and device deficiencies in clinical performance studies, including authoring reportability assessments
• Supporting the medical safety competency center by shaping and maintaining processes for effective medical risk evaluation and related activities
• Serving as a strong advocate for patient safety by anticipating challenges, advising on clinical workflows and environments, and helping to mitigate risks

We’re looking for someone who is collaborative, analytical, and passionate about making a difference in healthcare.

The essential requirements of the job include:

• Physician (MD or equivalent) or other advanced degree in a relevant field with 10+ years’ experience
• A minimum of 5 years’ experience with an excellent track record for safety and risk management within medical affairs, scientific affairs or similar within the industry (medical devices and/or pharmaceuticals)
• Experience with patient-centric and risk-based clinical input to R&D and vigilance cases
• Experience in providing medical and scientific input of safety related topics in regulatory-required documents
• Excellent verbal and written English communication skills along with outstanding stakeholder and change management skills

It would be an advantage if you also:

• Demonstrate strong teamwork skills and the ability to collaborate effectively with both internal and external stakeholders to support medical safety initiatives
• Bring experience in clinical laboratory testing of medical devices and/or in vitro diagnostics (IVDs), such as familiarity with ISO 14155
• Possess a solid understanding of Product Risk Management principles, including ISO 14971
• Have the capability to educate and communicate effectively within the organization regarding device usage, safety, and performance

Application

We review applications on an ongoing basis and invite candidates to interviews as soon as we identify a potential match. Therefore, we encourage you to apply as soon as possible.

We look forward to receiving your application.