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Regulatory Affairs Leader

3 weeks ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

At Radiometer Danmark / Danaher, we're pushing the boundaries of healthcare innovation. Our mission is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you'll play a vital 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, and will be an on-site position. You'll be working closely with stakeholders across the global organization to build a world-class regulatory affairs team. Your responsibilities will include overseeing and directing an awesome team of highly engaged associates, focusing on continuous development of the team.

The Role:

  • Drive Process Improvements: Develop and implement effective processes and procedures to ensure seamless regulatory support.
  • Implement Systems and Tools: Design and implement innovative systems and tools to enhance regulatory efficiency and effectiveness.
  • Global Regulatory Strategy: Collaborate with cross-functional teams to develop and implement global regulatory strategies that align with business objectives.
  • Team Leadership: Lead and motivate a high-performing team, fostering a culture of excellence and collaboration.

Requirements:

  • Bachelor's Degree: A degree in a technical field such as chemistry, biochemistry, biology, or related required.
  • Regulatory Experience: Minimum 7 years of experience in global IVD/MD regulations, quality standards, and design control required.
  • Negotiation Skills: Demonstrates excellent negotiation skills, problem-solving skills, and builds consensus.
  • Communication Skills: Excellent communication skills in written and oral channels both within Regulatory and across the organization.