Regulatory Affairs Manager

Job title:

Regulatory Affairs Manager

Company:

Danaher

Job description

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 Regulatory Affairs Manager for Radiometer is responsible for managing a product RA team and driving regulatory activities to support continued business growth and compliance worldwide.This position is part of the Global Regulatory Affairs team located primarily in Brønshøj, Denmark and will be on-site. Some international travel may occur. 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 a RA team that supports new product development and ensuring the market access is maintained worldwide with specific focus on EU, US and China. If you thrive in a fast-paced environment, is used to playing a critical supporting and coordinating role and want to work build and want to work to build a world-class regulatory affairs team —read on.In this role, you will have the opportunity to:

• Oversee and direct an awesome team of highly engaged associates and focus on continuous development of the team.
• Ensure development of regulatory strategies for product approvals and compliance
• Ensure adequate RA resources for planning and execution of RA activities related to R&D projects, compliance, lifecycle management and improvement projects
• Drive process improvements for RA owned processes and procedures.
• Work closely cross functionally with key stakeholders in a global environment

The essential requirements of the job include:

• Master’s degree in science, engineering, pharmacy, biology, biochemistry, biotechnology, medical technology, or similar
• 7+ years of regulatory experience related to MD/IVD
• 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.
• Experience with taking a product from development through global regulatory approval incl. EU and US and life cycle management.
• 3+ years of leadership and/or team management experience.

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

• Prior experience holding accountability and responsibility for global business metrics and application of data-based process improvements.
• Experience with meetings with regulatory bodies such as FDA and notified body

ApplicationWe continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. The recruitment will be completed as soon as a suitable candidate is found.We look forward to seeing your application.Please read our Applicant Data Privacy Notice carefullyJoin 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 .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.

Expected salary

Location

Brønshøj, København

Job date

Wed, 11 Dec 2024 03:04:36 GMT

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