Regulatory Affairs Leadership Position for Global Success

11 hours ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

Radiometer Danmark, part of Danaher, is dedicated to improving global healthcare with reliable, fast, and easy patient diagnoses.

This challenging role as Senior Manager, Regulatory Affairs Processes, Systems and Tools offers the opportunity to drive process improvements and implement systems and tools within Regulatory Affairs to support efficient regulatory support for the organization's growth.

The position is part of the Global Regulatory Affairs team located primarily in Copenhagen, Denmark. As an on-site position, you will be responsible for providing guidance and support to the organization during product development, post-market, and through market expansions globally with our product portfolio.

The Regulatory Affairs team ensures that defined regulatory strategies are effectively implemented and maintained in line with changing regulatory and business needs. If you thrive in a multifunctional leadership role working with stakeholders across the global organization and want to work towards building a world-class regulatory affairs team, this may be the right opportunity for you.

Key Responsibilities:

  • Oversee and direct an engaged team of associates, focusing on continuous development.
  • 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.
  • 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.
  • Minimum 7 years of regulatory experience related to medical device/in vitro diagnostics.
  • 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.

Desirable Qualifications:

  • Prior experience holding accountability and responsibility for global business metrics and application of data-based process improvements.

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