Regulatory Affairs Senior Manager
5 days ago
In a world where life is precious, our technology and solutions empower caregivers to make informed decisions that improve patient care.
At Radiometer Danmark/Danaher, our purpose is to unite over 4000 colleagues worldwide in a shared goal. We create impactful innovations that require persistence, passion, and a desire to make a difference.
The Senior Manager, RA Processes, Systems and Tools will drive process improvements and implement systems and tools within Regulatory Affairs to support efficient regulatory support for the organization and growth of the company.
This role is part of the Global Regulatory Affairs team, primarily located in Copenhagen, Denmark, and will be an on-site position. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
This role offers:
- Leadership of a team of associates and focus on continuous development
- Driving process improvements for RA owned processes and procedures
- Implementing systems and tools for efficient Regulatory Affairs operations
- Collaboration with stakeholders and cross-functional teams on regulatory intelligence and process implementation
- Daily Management and improvement opportunity funnel establishment
Requirements include:
- Bachelor's degree in a technical field such as chemistry, biochemistry, biology, or related required
- Experience in global IVD/MD regulations, quality standards, and design control required
- Minimum 7 years of regulatory experience related to medical device/in vitro diagnostics required
- Excellent negotiation, problem-solving, and communication skills
- Experience working in a complex matrix environment
Prior experience in global business metrics and data-based process improvements is a plus
Apply today and be part of our team
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