Regulatory Affairs Professional Medical Devices
2 weeks ago
We are looking for a highly skilled Regulatory Affairs Professional to join our team at Radiobotics. As a key member of our Clinical and Regulatory department, you will play a crucial role in maintaining superior product quality and driving growth into new markets. Your main tasks will include co-driving product release projects, supporting other departments in design control, and taking lead on risk analysis for new products.
About UsAt Radiobotics, we believe in transparency, integrity, and open communication. Our vision is to solve the global need for radiologists while ensuring every patient receives expert-level care. We strive to learn what happens beyond the surface and show up every day ready to engage and have fun with each other.
- A master's degree in healthcare, medical, or life science
- A positive can-do attitude with a thorough and structured mindset
- Excellent communication skills in English and experience working within or leading cross-functional projects
- Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485, and ideally 21 CFR
- Experience with Software as a Medical Device
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Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeWe are Radiobotics, a company driven by aspiration, curiosity, and playfulness. We believe in integrity, transparency, and open communication. Our vision is to augment routine X-rays of the musculoskeletal system, enabling non-specialists to read radiology images assisted by our products, and ensuring patients have access to immediate expert-level evaluation...
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Medical Device Regulatory Affairs Expert
2 weeks 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 Specialist
4 days ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeAbout the Role:This is a temporary consultancy position to support our permanent hire search.We seek an experienced QA/RA specialist with a strong background in product registrations and quality management systems. The ideal candidate will have a flair for product quality, be curious about new markets, and passionate about medical device software.The...
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Regulatory Affairs Specialist in Medical Devices
2 weeks ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeWe're on a mission to solve the global need for radiologists while ensuring every patient receives expert-level care. Our vision is that all routine X-rays of the musculoskeletal system are augmented and first-line reported by our products.About Us:Radiobotics is driven by aspiration, curiosity, and playfulness. We believe in transparency, integrity, and...
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Medical Device Compliance Manager
7 days ago
Copenhagen, Copenhagen, Denmark European Federation Of Organizations For Medical Physics - EFOMP Full timeJob Overview:About UsWe are a small team dedicated to bringing innovative solutions to the field of dental radiology. Our mission is to bring CBCT scanning to the next level by enabling true motion correction and high fidelity scanning to clinics across the world.We are looking for a Regulatory Affairs Quality Specialist to join our team. As a Regulatory...
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Medical Device Regulatory Lead
6 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Regulatory Affairs Director at Black Swans Exist is responsible for ensuring the company's products meet global regulatory requirements. This position involves developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical devices, and ensuring timely updates for existing products.Key...
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Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeCompany Overview">Radiobotics is a leading company in the medical technology field, dedicated to developing innovative solutions for radiology imaging.Salary">Competitive salary based on experience and qualifications.Job Description">As a Senior QA/RA Expert, you will play a crucial role in ensuring the quality and regulatory compliance of our medical...
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Regulatory Affairs Specialist
6 days ago
Copenhagen, Copenhagen, Denmark Amoria Bond Full timeRegulatory Affairs Specialist (MedTech) – 6 Month Contract | CopenhagenOn behalf of an exciting client in the medical device industry, we are looking for a Regulatory Affairs Specialist for a 6-month freelance assignment based in Copenhagen.You will support regulatory activities for innovative medical devices, ensuring compliance with MDR and other...
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Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics is committed to solving the global need for radiologists while ensuring every patient receives expert-level care. Our vision is to enable the reading of radiology images by non-specialists assisted by our products, and facilitate that non-critical imaging is safely and effectively handled outside the hospital.We are seeking a qualified Quality...
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Medical Device Quality Assurance Specialist
5 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeAt Radiobotics, we're seeking an experienced Medical Device Quality Assurance Specialist to join our Clinical and Regulatory team. This is a unique opportunity to work on the development of innovative medical software solutions and take a lead role in ensuring the highest quality standards are met.The ideal candidate will have a strong background in quality...
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Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeJob DescriptionRadiobotics Copenhagen Full-time We are seeking a highly skilled QA/RA specialist to join our Clinical and Regulatory team. As a key member of the team, you will be responsible for maintaining superior product quality and ensuring compliance with regulatory requirements.About the Role:Co-driving product release projects in collaboration with...
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Medical Device Quality Assurance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeAre you passionate about ensuring the highest quality in medical devices? Do you have experience with regulatory affairs and a strong understanding of quality management systems? We are seeking a highly skilled Regulatory Affairs Professional to join our team. As a key member of our Clinical and Regulatory department, you will play a crucial role in...
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Medical Device Compliance Specialist
6 days ago
Copenhagen, Copenhagen, Denmark Amoria Bond Full timeJob DescriptionWe are seeking an experienced Regulatory Affairs Specialist to support our client, a prominent company in the MedTech sector.Ensure compliance with EU regulations, specifically the Medical Device Regulation (MDR).Prepare and maintain technical documentation in accordance with MDR requirements.Support regulatory submissions and communication...
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Director of Regulatory Affairs
3 weeks ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Director of Regulatory Affairs ensures that the company's products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical...
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Regulatory Affairs Manager
2 weeks 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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Regulatory Affairs Director
4 days ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeCompany OverviewRadiometer Danmark / Danaher is a leading company in the diagnostics industry, working towards improving global healthcare with reliable, fast, and easy patient diagnoses. We are proud to work alongside a community of six fellow Diagnostics Companies at Danaher.Job DescriptionThe Senior Manager, RA Processes, Systems and Tools for Radiometer...
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Medical Devices Quality Assurance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full timeAbout UsFerrosan Medical Devices A/S is a leading international company developing and producing medical devices used in surgical care. Our portfolio consists of various hemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies.Our MissionWe are driven by improving patient outcomes and...
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Medical Device Quality Assurance Consultant
2 weeks ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeAt Radiobotics, we're seeking a seasoned QA/RA professional to join our Clinical and Regulatory team. The ideal candidate will have at least 1 year of experience in quality assurance and/or regulatory affairs within the medical device field.Job Description:Define and deliver on our strategy to maintain superior product qualityTake lead on placing products...
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Medical Device Manufacturing Expert
5 days ago
Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full timeWe are expanding our production capability as we are approaching new markets with our products. For that, we need a new colleague to join our Technology Innovation department.As a Senior Project Engineer at Ferrosan Medical Devices A/S, you will be responsible for specifying next-generation manufacturing equipment for out-sourced manufacturing processes. You...
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Senior Medical Affairs Professional
2 weeks ago
Copenhagen, Copenhagen, Denmark LEO Pharma Full timeWe are seeking a Senior Medical Affairs Professional to lead our Medical team in Oncology.As a Medical Lead, you will be responsible for developing and implementing global medical strategies and plans to ensure integration and successful execution of Medical Affairs activities from both local and global Medical plans for Oncology.The ideal candidate will...