Regulatory Affairs Manager for Global Compliance and Innovation

3 days ago


Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

Radiometer Danmark/Danaher is a leading company in the diagnostics industry, dedicated to improving global healthcare with reliable, fast, and easy patient diagnoses. As a Senior Manager, RA Processes, Systems and Tools, you will play a crucial role in driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for the organization and growth of the company.

This position is part of the Global Regulatory Affairs team located primarily in Copenhagen, Denmark. You will be responsible for overseeing and directing an awesome team of highly engaged associates, focusing on continuous development of the team. Additionally, you will drive process improvements for RA owned processes and procedures, implement systems and tools that support the Regulatory Affairs organization towards a more efficient way of working.

The ideal candidate will have a minimum bachelor's degree in a technical field such as chemistry, biochemistry, biology, or related. They should possess 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. A minimum of 7 years of regulatory experience related to medical device/in vitro diagnostics is required.

Key responsibilities include:

  • Overseeing and directing a team of associates
  • Driving process improvements for RA owned processes and procedures
  • Implementing systems and tools to support Regulatory Affairs efficiency
  • Working with key stakeholders and cross-functional teams to monitor, interpret, and implement new legislation, standards, and guidance

We offer a competitive salary of approximately €80,000 - €110,000 per year, depending on qualifications and experience. If you thrive in a multifunctional leadership role, working with stakeholders across the global organization, and want to build a world-class regulatory affairs team, read on.

We are looking for a highly skilled and experienced professional to join our team. If you meet the requirements and are passionate about regulatory affairs, please apply. We look forward to seeing your application.



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