Regulatory Affairs Director

3 days ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

At Radiometer Danmark, we're committed to improving global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our Global Regulatory Affairs team, you'll play a crucial role in driving process improvements and implementing systems and tools to support efficient regulatory support for the organization and growth of the company.

Job Description:
  • 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 such as MAPSS (Marketing, Advertising, Promotional, Scientific, and Sales) material.
  • 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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