Global Regulatory Strategy Director
7 days ago
Transforming Healthcare Through Regulatory Excellence
Radiometer Danmark / Danaher is at the forefront of developing diagnostic solutions that improve health outcomes worldwide. Our commitment to regulatory excellence enables us to bring life-changing technologies to market efficiently and safely.
The Senior Manager, RA Processes, Systems and Tools is a critical role in driving process improvements and implementing systems and tools within Regulatory Affairs. This position is part of the Global Regulatory Affairs team based in Copenhagen, Denmark and will be an on-site position.
As a key member of the leadership team, you will report to the Sr Director Regulatory Affairs responsible for global regulatory strategy and tactical planning. The Regulatory Affairs team ensures that regulatory strategies are effectively implemented and maintained, aligning with changing regulatory and business requirements.
Your responsibilities will include:
- Leading a high-performing team and focusing on their continuous development.
- Driving process improvements for RA-owned processes and procedures.
- Implementing systems and tools to enhance Regulatory Affairs efficiency.
- Collaborating with cross-functional teams to monitor, interpret, and implement new/changed legislation, standards, and guidance.
To be successful in this role, you must possess:
- A minimum bachelor's degree in a relevant technical field.
- Extensive knowledge and experience in global IVD/MD regulations, quality standards, and design control.
- A minimum of 7 years of regulatory experience in medical devices/in vitro diagnostics.
- Excellent negotiation, problem-solving, and communication skills.
- Ability to work in a complex matrix environment.
Prior experience in applying data-based process improvements and managing global business metrics would be advantageous.
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