Regulatory Affairs Process Manager, Global Innovations

1 week ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

At Radiometer Danmark / Danaher, we're committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We're seeking a highly skilled Senior Manager, RA Processes, Systems and Tools to join our team.

The ideal candidate will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for the organization's growth. This role is part of the Global Regulatory Affairs team located in Copenhagen, Denmark, and will be an on-site position.

As a member of the Regulatory Affairs leadership team, you will report to the Sr Director Regulatory Affairs, responsible for global regulatory strategy and tactical planning. You will provide guidance and support to the organization during product development, as well as 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 fast-paced, multifunctional leadership role working with stakeholders across the global organization, this may be the perfect opportunity for you.

Key Responsibilities:
  • Oversight and direction of an awesome team of highly engaged associates, focusing on continuous development.
  • Driving process improvements for RA-owned processes and procedures.
  • Implementing systems and tools to support the Regulatory Affairs organization towards a more efficient way of working.
  • Collaboration with key stakeholders and cross-functional teams to monitor, interpret, and implement new/changed legislation, standards, and guidance.

We're looking for a seasoned professional with a strong background in global IVD/MD regulations, quality standards, and experience working in a complex matrix environment. Your excellent negotiation skills, problem-solving abilities, and effective communication skills will enable you to build consensus and deliver challenging messages effectively.

This role requires a minimum of 7 years of regulatory experience related to medical devices/in vitro diagnostics, along with a bachelor's degree in a technical field such as chemistry, biochemistry, biology, or a related field.

Estimated Salary: $120,000 - $180,000 per year, depending on experience and qualifications.

About Us:

Radiometer Danmark / Danaher is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

We encourage applicants with prior experience holding accountability and responsibility for global business metrics and application of data-based process improvements to apply.

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