Regulatory Affairs Systems Manager

4 days ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

Radiometer Danmark / Danaher is a leading provider of diagnostic solutions. Our purpose is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you will be responsible for 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 role is part of the Global Regulatory Affairs team located primarily in Copenhagen, Denmark and will be an on-site position. At Radiometer Danmark / Danaher, we are committed to creating impactful innovations that make a difference in people's lives. If you thrive in an amazing, multifunctional, leadership environment working with stakeholders across the global organization and want to work to build a world-class regulatory affairs team - read on.

Key Responsibilities:

  • Oversee and direct an awesome team of highly engaged associates and focus on continuous development of the team.
  • 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.
  • Work with key stakeholders and a cross-functional team monitoring, interpreting, and implementing new/changed legislation, standards, and guidance through the Regulatory Intelligence process and other processes.
  • Establish and drive Daily Management in RA as well as the improvement opportunity funnel.

Requirements:

  • Minimum bachelor's degree in a technical field such as chemistry, biochemistry, biology, or related required.
  • 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. required.
  • Minimum 7 years of regulatory experience related to medical device/in vitro diagnostics required.
  • Demonstrates excellent negotiation skills, problem-solving skills and builds consensus.
  • Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
  • Able to deliver challenging messages effectively without compromising important business relationships.
  • Experience working in a complex matrix environment.

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