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Head of Regulatory Systems and Tools

2 weeks ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

We're seeking a talented individual to join our Global Regulatory Affairs team as a Head of Regulatory Systems and Tools. This exciting role will involve driving process improvements and implementing systems and tools 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 work closely with stakeholders across the global organization to build a world-class regulatory affairs team. Your responsibilities will include designing and implementing innovative systems and tools to enhance regulatory efficiency and effectiveness.

Key Responsibilities:

  • System Development: Design and implement innovative systems and tools to enhance regulatory efficiency and effectiveness.
  • Process Improvement: Identify areas for improvement and develop effective solutions to streamline regulatory processes.
  • Global Regulatory Strategy: Collaborate with cross-functional teams to develop and implement global regulatory strategies that align with business objectives.
  • Team Management: 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.