Medical Device Regulatory Lead
5 days ago
The 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 Skills:- Regulatory Expertise: Deep expertise in drug regulations and approvals.
- Leadership: Ability to lead a global team and interpret regulatory changes.
- Communication: Excellent communication skills to collaborate with internal stakeholders.
A master's degree in a related field is preferred, along with experience in nuclear medicine, diagnostics, or regulatory support for combination product development.
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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 Compliance Manager
6 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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Regulatory Affairs Professional Medical Devices
2 weeks ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeWe 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...
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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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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
3 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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Medical Device Quality Assurance Specialist
4 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 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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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 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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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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Quality Assurance Manager for Medical Devices
2 weeks ago
Copenhagen, Copenhagen, Denmark Corti Full timeJoin our team at Corti as we work together to revolutionize the dialogue in healthcare. As a Compliance and Risk Management Lead, you will be responsible for ensuring our products and services meet the highest standards of quality and compliance.About the CompanyCorti has built the world's premier AI assistant for healthcare providers. It listens in during...
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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
5 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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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 QA/RA specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics Copenhagen Full-timeSalary CompetitiveDo you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe you...
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Medical device QA/RA Consultant
2 weeks ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics Copenhagen Freelance Part-timeSalary CompetitiveThis is a temporary consultancy position to support while we search for a permanent hireDo you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a...
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Medical device QA/RA Consultant
4 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics Copenhagen Freelance Part-time Salary Competitive This is a temporary consultancy position to support while we search for a permanent hire Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations...
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Medical device QA/RA specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeDo you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe you are a seasoned QA specialist that would like to...
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Medical device QA/RA Consultant
2 weeks ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeThis is a temporary consultancy position to support while we search for a permanent hireDo you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with...