Regulatory Affairs Director

3 days ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

Radiometer Danmark/Danaher is proud to work at the forefront of diagnostic innovation. Our shared purpose unites over 4000 employees worldwide in a pursuit to improve patient care through technology and solutions.

We are seeking an exceptional individual to join our Global Regulatory Affairs team as Senior Manager, RA Processes, Systems and Tools.

As part of this role, you will oversee process improvements and implement systems and tools within Regulatory Affairs to support efficient regulatory support for the organization and growth of the company.

This position is based primarily in Copenhagen, Denmark and will be an on-site role. At Radiometer, our vision is to enhance global healthcare with reliable, fast, and easy patient diagnoses.

You will be a key member of the Regulatory Affairs leadership team, reporting to the Sr Director Regulatory Affairs responsible for global regulatory strategy and tactical planning. This involves providing guidance and support to the organization during product development, post-market, and 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.

In this role, you will have the opportunity to:

  • Directly supervise and develop a high-performing team of associates.
  • 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.
  • Collaborate with cross-functional teams to monitor, interpret, and implement new/changed legislation, standards, and guidance through the Regulatory Intelligence process.

Key qualifications for this role include:

  • A minimum of a bachelor's degree in a technical field such as chemistry, biochemistry, biology, or related required.
  • Demonstrated knowledge and experience in global IVD/MD regulations, quality standards, and design control, risk management, etc. required.
  • A minimum of 7 years of regulatory experience related to medical device/in vitro diagnostics required.
  • Excellent negotiation skills, problem-solving skills, and consensus building abilities required.
  • Effective communication skills in written and oral channels within Regulatory and across the organization required.

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