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.

As our Senior Director of Global Regulatory Affairs, you will play a critical role in ensuring that our company is in compliance with all relevant regulations and standards. You will lead a team of 50 regulatory professionals and work closely with cross-functional teams to develop and execute regulatory strategies that support our business objectives. You will be accountable for the performance and results of the RA organization, including compliance, audit preparation and completeness, and growth initiatives such as registrations and submissions.

This position is part of Global RA/QA located in Denmark and it will be a hybrid setup as we have a flexible working environment with the opportunity to regularly working from home. You will be a part of our Senior RA/QA Leadership Team and report to the VP of Global RA/QA.

At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. To support this vision, we are seeking a highly experienced regulatory affairs professional who can lead our organization through the ever-changing regulatory landscape, while driving cross-functional collaboration and continuous improvement, and maintaining the highest levels of compliance. If you are passionate about making a difference in patients' lives through innovative and compliant products, you might be the right candidate for this position?

In this role, you will have the opportunity to:

• Develop and implement regulatory strategies for successful product approvals.

• Provide strategic guidance to cross-functional teams on regulatory requirements and risks.

• Ensure compliance with relevant regulations and standards by developing and maintaining policies and procedures.

• Identify and communicate potential regulatory risks to senior leadership.

• Build and maintain strong relationships with key stakeholders, including regulatory agencies, industry associations, and other external partners, to partner for impact.

• Manage and develop a high-performing team of regulatory professionals.

• Prioritize the wellbeing, talent, and organizational development of the RA department.

• Lead through Danaher Business System (DBS) tools to drive continuous improvement.

The essential requirements of the job include:

• Demonstrated success in leading teams and driving change in a global and dynamic environment.

• 10-15 years of professional experience in medical device regulatory affairs, including leadership of QA/RA or regulatory affairs for a complex business unit.

• In-depth knowledge of FDA regulations, guidelines, and submissions. Stay updated on changes to regulations, standards, and guidelines worldwide, as well as industry trends and best practices.

• Strong commitment to quality and compliance, with excellent organizational skills.

• High level of initiative, self-motivation, and customer focus with a visionary approach.

• Reliable and responsive in all aspects of work.

• Master's degree or PhD in a science, engineering, medical, or technical field.

• Proven track record of successful regulatory strategies, clearances, and approvals, including experience with international audits and negotiations with regulators.

Application

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

We encourage you to apply before end of business on 23rd June 2024. If you have questions, feel free to contact Vice President, RA/QA, Medha Avisetti at medha.avisetti@radiometer.dk. We look forward to seeing your application.

We thank you for your interest. Please read our Applicant Data Privacy Notice carefully here. (https://www.danaher.com/data-privacy-policy)

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.

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.

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.