Regulatory Affairs Expert
5 days ago
As a Regulatory Affairs Expert at Radiometer Danmark, you will play a critical role in ensuring compliance with applicable standards and regulations within the organization. You will be responsible for handling quality management systems and supporting processes, participating in and driving smaller projects in the RA/QA function with manageable risks and resource requirements, and guiding the organization during external audits.
To be successful in this role, you should have a Master's degree in Engineering, Pharmacy, Biology, Biochemistry, or similar, and at least 5 years of in-depth knowledge and experience with applicable standards and regulatory requirements (ISO 13485, IVDD/IVDR, MDR, and FDA legislation) from a QA job function. You should also possess excellent communication and stakeholder management skills, as well as proficiency in spoken and written English and Danish language skills.
If you are passionate about working in a cross-functional and fast-paced environment, and want to build a world-class QA organization, we encourage you to apply.
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Regulatory Affairs Expert
5 days ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeWe are seeking a dedicated and experienced Regulatory Affairs Manager to join our team at Oresund Pharma ApS.Job Description:The successful candidate will be responsible for developing and maintaining a global product portfolio following regulatory requirements and commercial demands. Key responsibilities include lifecycle management, ensuring products...
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Medical Device Regulatory Affairs Expert
2 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeIn this exciting role as Medical Device Regulatory Affairs Expert, you will be responsible for ensuring that our products comply with relevant regulatory requirements. You will work closely with cross-functional teams to drive product releases and ensure that our products meet the highest standards of quality and safety.A key aspect of this role is staying...
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Regulatory Affairs Leader
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking an experienced leader to join our Global Regulatory Affairs organization as a Senior Director, Regulatory Affairs Strategy-EU/RoW. This role will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products.The ideal candidate will have a strong...
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Regulatory Affairs Manager
2 days ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeInnovative solutions for a better tomorrowRadiometer Danmark / Danaher is committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We strive to make a difference in people's lives by providing cutting-edge technology and solutions.The Senior Manager, RA Processes, Systems and Tools plays a crucial role in driving process...
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Director of Regulatory Affairs
2 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeGet AI-powered advice on this job and more exclusive features.Senior Business Development Consultant at Black Swans ExistDirector of Regulatory AffairsAre you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a...
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Regulatory Affairs Director
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the PositionWe are seeking a highly skilled Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will have the opportunity to utilize your expertise to drive regulatory compliance and quality in clinical trials.ResponsibilitiesDrive regulatory compliance and quality in...
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Global Regulatory Affairs Manager
5 days ago
Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full timeSandoz International GmbH is a leading generic and biosimilar medicines company, committed to improving access to high-quality, low-cost medicines for patients worldwide. We are seeking a highly motivated Global Regulatory Affairs Manager to join our LCM Product team.In this role, you will be responsible for managing global regulatory affairs, including...
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Senior Counsel, Regulatory Affairs
2 days ago
Copenhagen, Copenhagen, Denmark MasterCard Full timeSenior Counsel, Regulatory AffairsSenior Counsel, Regulatory AffairsApply locations Copenhagen, Denmark time type Full time posted on Posted 22 Days Ago job requisition id R-242297Our PurposeMastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where...
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Regulatory Affairs Lawyer
2 days ago
Copenhagen, Copenhagen, Denmark MasterCard Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Lawyer to join our team in Copenhagen, Denmark. As Senior Counsel for Open Banking, you will play a key role in facilitating the strategic development of Mastercard's open banking business in Europe.Key ResponsibilitiesRegulatory Compliance: Ensure that Mastercard's European subsidiaries are...
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Biotechnology Regulatory Affairs Expert
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeCompany OverviewGenmab is a leading biotechnology company with a strong commitment to improving the lives of patients through innovative and differentiated antibody therapeutics. With a core purpose guiding its unstoppable team, Genmab strives towards transforming the lives of people with cancer and other serious diseases.About the RoleThe Regulatory Affairs...
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Regulatory Affairs Specialist
5 days ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeWe are seeking a dedicated and experienced Regulatory Affairs Manager.As part of our team, you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a global product portfolio following regulatory requirements and commercial demands.As Regulatory Affairs Manager, you will be responsible for your own portfolio...
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Regulatory Affairs Manager
4 days ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeWe are looking for a new colleague to join our Regulatory department. Oresund Pharma is seeking a dedicated and experienced Regulatory Affairs Manager; in this role you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a product portfolio following regulatory requirements and commercial demands. As a...
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Regulatory Affairs Systems Manager
7 days ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark / Danaher is a leading provider of diagnostic solutions. Our purpose is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for...
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Regulatory Affairs Professional
5 days ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeOresund Pharma ApS is seeking a dedicated and experienced Regulatory Affairs Manager to join our team.Responsibilities:Lifecycle management of productsEnsuring compliance with regulationsPreparation and review of regulatory submissionsMaintenance of product informationMonitoring and setting timelinesKeeping up-to-date with legislation and...
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Biotech Regulatory Affairs Lead
2 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeAbout Black Swans ExistBlack Swans Exist is a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health. We are shaping the future of women's health by developing innovative biologics and combination drug-device products.The RoleWe seek a visionary Director of Regulatory Affairs to lead our global regulatory...
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Regulatory Affairs Director for Biologics
2 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeCompany OverviewBlack Swans Exist is a pioneering biotech company dedicated to revolutionizing microbiome-based therapies for women's reproductive health. Our vision is to develop innovative biologics and combination drug-device products that improve women's lives.The PositionWe're seeking an experienced Director of Regulatory Affairs to lead our global...
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Global Regulatory Expert
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the JobGenmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.We are seeking a talented individual to join our Global Regulatory Affairs organization as a Senior Director, Regulatory Affairs...
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Regulatory Affairs Professional
3 days ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeWe are seeking an experienced Regulatory Affairs Professional to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and commercial demands worldwide.As a key member of our Regulatory department, you will be the center of product maintenance activities, aware of your stakeholders, and understand the full...
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Regulatory Affairs Expert
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeInnovative Antibody Therapies: Collaboration OpportunityJob DescriptionWe're seeking a seasoned expert in regulatory stability to join our CMC Stability team in Denmark. As a key contributor to our Clinical Pipeline, you will play a vital role in managing stability activities and collaborating with internal and external stakeholders.Your responsibilities...
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Regulatory Affairs Director
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeOur CultureGenmab fosters a culture of collaboration, mutual respect, and open communication. Our team is composed of talented individuals who share a passion for innovation and excellence. We strive to create an environment where every employee feels valued, supported, and empowered to contribute to our shared success.About the PositionWe're seeking a...