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Senior Manager Regulatory Compliance

3 weeks ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

As a Senior Manager at Radiometer Danmark / Danaher, you'll have the opportunity to make a significant impact on our Regulatory Affairs function. We're seeking an experienced professional to drive process improvements and implement 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 directing an awesome team of highly engaged associates, focusing on continuous development of the team.

Key Responsibilities:

  • Process Improvement: Identify areas for improvement and develop effective solutions to streamline regulatory processes.
  • System Implementation: 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 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.