Global Regulatory Strategist
5 days ago
Radiometer Danmark is committed to improving global healthcare with reliable, fast, and easy patient diagnoses. Our Global Regulatory Affairs team plays a crucial role in this effort, and we're seeking a skilled Senior Manager to join our team.
About the Team:- Our team is responsible for driving process improvements and implementing systems and tools to support efficient regulatory support for the organization and growth of the company.
- We work closely 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 such as MAPSS (Marketing, Advertising, Promotional, Scientific, and Sales) material.
- We establish and drive Daily Management in RA as well as the improvement opportunity funnel.
- You have a strong background in regulatory affairs, with a minimum 7 years of experience related to medical device/in vitro diagnostics.
- You have 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.
- You demonstrate excellent negotiation skills, problem-solving skills and build consensus.
- You demonstrate effective communication skills in written and oral channels both within Regulatory and across the organization.
- You are able to deliver challenging messages effectively without compromising important business relationships.
- You have experience working in a complex matrix environment.
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Copenhagen, Copenhagen, Denmark Genmab Full timeWe're seeking a talented and motivated Senior Director to lead our Regulatory Affairs function.In this role, you'll be responsible for developing global regulatory strategies for our portfolio of development pipeline candidate drugs and marketed products.You'll provide strategic input and ensure operational execution of global submission activities,...
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com.Director/Associate Director, Global Regulatory Affairs - CMCAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering...
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Director/Associate Director, Global Regulatory Affairs - CMC At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that...