Medical Device Project Specialist
2 weeks ago
At °MEQU, we are a fast-growing MedTech scale-up dedicated to developing medical devices that shape the future of critical care. We empower healthcare professionals to combat hypothermia and save lives with our innovative °M Warmer System, a portable blood and IV fluid warmer that heats fluids to body temperature within seconds.
We have achieved CE-marking in 2018 and U.S. FDA 510(k) clearance in May 2024, and we continue to deliver cutting-edge, user-friendly healthcare solutions. Our team is characterized by a strong culture of cross-functional collaboration and a striving to optimize working processes.
We are seeking a highly skilled Project Engineer to join our Research & Development Department. As our new Project Engineer, you will play a key role in ensuring technical excellence and compliance in our development of medical devices.
The successful candidate will be responsible for driving technical implementation of product changes/improvements along with validation and verification activities based on statistical data. You will also write technical protocols according to requirements for product testing, conduct product testing, and ensure fulfillment of criteria and requirements.
In addition, you will foster a collaborative and motivating team environment to drive project success, ensure project execution and coordination across disciplines and departments in the organisation, and ensure compliance with international standards including ensuring delivery of all documentation.
You will work closely with colleagues in RA/QA, Operations and Sales/Marketing to achieve common goals. If you are a strong collaborator who actively engages in project work and coordination across disciplines and departments in the organization, this may be the opportunity for you.
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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 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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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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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 Expert
2 weeks ago
Copenhagen, Copenhagen, Denmark Pharmalogic Full timePharmalogic ApS is a dedicated consultancy services provider within the life science industry, offering expertise in various areas. As experienced specialists or temporary employees, we ensure quality and meet deadlines.We are organized into different sections based on background and experience: Fill & FinishAPIMedical DeviceIT & AutomationOur mission is to...
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Medical Device Specialist
4 days ago
Copenhagen, Copenhagen, Denmark European Federation Of Organizations For Medical Physics - EFOMP Full time**Job Summary**We are expanding our organization around the X1 CBCT unit and need a skilled hardware validation professional to manage the certification process. The successful candidate will plan and execute the certification process, including pre-testing in our own facility and participating in certification testing.The ideal candidate will have a strong...
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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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Senior QA Engineer
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Copenhagen, Copenhagen, Denmark 3Shape Full timeAs a Quality Assurance Specialist at 3Shape, you will be part of our cross-functional team responsible for developing scanner systems for the medical device domain. Your primary focus will be on improving the quality aspect in our development projects.
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Medical Device Manufacturing Expert
4 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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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 Supply Chain Specialist
5 days ago
Copenhagen, Copenhagen, Denmark ˚MEQU Full timeAt °MEQU, we empower healthcare professionals to combat hypothermia and save lives. As our new Medical Device Supply Chain Specialist, you will be part of our Operations department and play a vital role in ensuring the smooth delivery of our products.This is an excellent opportunity for a seasoned professional to join our team and contribute to the fast...
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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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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 Marketing Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Agilent Technologies Full timeKey ResponsibilitiesDevelop and execute go-to-market strategies for companion diagnostic products.Own the life cycle of companion diagnostic products, including strategy and business cases.Ensure market and customer requirements for new diagnostic assays are met.Drive product launches and promotions in global markets.Collaborate with pharma partners to plan...
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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 Engineer
2 weeks ago
Copenhagen, Copenhagen, Denmark H3D Full timeThe OpportunityYou will join our core engineering team as a key contributor to AutoDesign, our trailblazing cloud platform that's transforming how medical devices are designed and manufactured.This isn't just another web application - you'll be working with 3D visualization, machine learning pipelines, and cloud infrastructure to tackle real-world problems....
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Senior Medical Device Professional
2 weeks ago
Copenhagen, Copenhagen, Denmark Pharmalogic Full timePharmalogic – Great People – Great Place to Work Pharmalogic ApS is a small, dedicated firm offering professional consultancy services within the life science industry. We provide expertise in various areas, acting as experienced specialists or temporary employees to ensure quality and meet deadlines. Our mission is to support the industry in achieving...
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Device Development Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Pharmalogic Full timeWe are a professional consultancy services provider within the life science industry, offering expertise in various areas. Our team consists of experienced specialists or temporary employees who ensure quality and meet deadlines.We are organized into different sections based on background and experience: Fill & FinishAPIMedical DeviceIT & AutomationJob...
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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...