Senior Regulatory Affairs Scientist
Radiometer

Job Info

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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 Senior Regulatory Scientist for Radiometer is responsible for regulatory and scientific guidance through all phases of a project and product life cycle to support continued business growth and compliance worldwide.

This position is part of the Global Regulatory Affairs team located primarily in New Brighton, MN and will be REMOTE. Some international travel to the Danish office in Brønshøj, Denmark is to be expected. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Regulatory Affairs and Quality Affairs and report to the Director, Regulatory Affairs responsible for an RA team that supports new product development and ensures market access is maintained worldwide with specific focus on EU, US and China. If you thrive in a fast-paced environment, are used to playing a critical supporting and coordinating role and want to work to build a world-class regulatory affairs team -read on.

In this role, you will have the opportunity to:

• Provide regulatory guidance through all phases of a project, research and development, pre-clinical and clinical testing, and final data analysis and write specific sections of regulatory submissions
• Provide regulatory and scientific guidance and mentoring of SMEs in different functional areas
• Advise on regulatory strategy and submissions based on the latest regulatory bodies thinking and guidelines (e.g. FDA, EU, ICH, etc.).
• Assist the project teams in developing and interpreting valid scientific evidence to demonstrate that the device meets the requirements and expectations of regulatory bodies on safety, efficacy, quality and performance.

The essential requirements of the job include:

• Bachelor's degree or master's in a scientific field (, engineering, pharmacy, biology, biochemistry, biotechnology, medical technology, or similar)
• At least 10 years' combined work experience with Regulatory Affairs and 3 years' experience in a scientific field
• Knowledge and experience in global IVD/MD regulations, quality standards such as ISO 13485, US FDA 21 Part 820, IVDR/MDR, design control, risk management, etc.
• Regulatory experience with taking a product from development through regulatory approval in US and life cycle management, including interactions with regulatory bodies such as FDA and notified bodies
• Good understanding of statistical methods and analysis

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

• Experience with giving both scientific and regulatory input to claims, test plans, test protocols (non-clinical and clinical)
• Detailed knowledge about other technical or SME areas such as software, usability, stability, clinical, post market surveillance

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

The salary range for this role is $120k - $145k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

#LI-LCS

Join our winning team today. Together, we'll 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.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

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