Regulatory Affairs Consultant for Medical Devices
2 days ago
We are Radiobotics ApS, a company driven by aspiration, curiosity, and playfulness. Our mission 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 engage with each other in a fun and dynamic environment.
We are seeking a highly experienced QA/RA specialist who can work independently and as part of a cross-functional team. The ideal candidate will have at least 1 year of experience within quality assurance and/or regulatory affairs, a master's degree in healthcare, medical, or life science, and excellent communication skills in English. They should also have knowledge of quality management systems and regulatory requirements within MDR and ISO 13485.
The successful candidate will be responsible for defining and delivering on our strategy to maintain superior product quality, taking lead on placing our products into new markets, and ensuring our internal quality processes are well-oiled. They will also assist in creating and coordinating product submissions, reviewing and revising QMS procedures, and participating in audits.
As a member of our team, you will enjoy flexible working hours, free coffee and tea, social gatherings, free office snacks, and free Friday beers. Our office is conveniently located near public transit, making it easy to commute.
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Pharmaceutical Regulatory Affairs Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeRegulatory Affairs Document SpecialistWe are seeking a highly skilled Regulatory Affairs Document Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6,...
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Medical device QA/RA Consultant
3 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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Senior/Principal Medical Writing Consultants
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Copenhagen, Copenhagen, Denmark Pharma IT Full timeSenior/Principal Medical Writing Consultants Pharma IT is hiring experienced Senior/Principal Medical Writer Consultants to join our Regulatory Affairs & Medical Writing Team In this role, you will work as a consultant to support our clients in the Pharma, Biotech and Medical Device industries. In this position, you will work on-site at the client's...
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Regulatory Affairs Professional
2 days ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark/Danaher is a leading company in diagnostics, partnering with customers across the globe to help them solve their most complex challenges. We're looking for a highly skilled Regulatory Affairs Professional to join our team and contribute to our mission.The successful candidate will possess an MSc in Engineering, Pharmacy, Biology,...
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Medical Device Project Manager
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Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full timeAbout the JobWe are seeking a Medical Device Project Manager to join our Technology Innovation department. As a key member of our project team, you will be responsible for specifying next-generation manufacturing equipment for out-sourced manufacturing processes.Your primary focus will be on collaborating with external partners to prepare user requirement...
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Medical Writing Specialist
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Copenhagen, Copenhagen, Denmark Pharma IT Full timeJob DescriptionWe are seeking a Senior/Principal Medical Writing Consultant to join our team. As a key member of our Regulatory Affairs & Medical Writing Team, you will work as a consultant to support our clients in the Pharma, Biotech, and Medical Device industries.In this role, you will be responsible for writing and reviewing clinical (and nonclinical)...
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Medical Writing Expert Consultant
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Copenhagen, Copenhagen, Denmark Pharma IT Full timeClinical Documentation SpecialistWe are looking for a skilled Clinical Documentation Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6, integrated...
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Regulatory Affairs Manager
22 hours ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeJob Description Summary LOCATION: Copenhagen, DenmarkROLE TYPE: Hybrid working (3 days per week in the office) As a member of the Regulatory Affairs (RA) team in Copenhagen, you will get the opportunity to work in a dynamic, agile team who has a common goal to bring our medicines to patients. We are looking for a Regulatory Affairs Manager or...
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Senior Medical Content Specialist
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Copenhagen, Copenhagen, Denmark Pharma IT Full timeMedical Writing Expert ConsultantWe are seeking an experienced Medical Writing Expert Consultant to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will work as a consultant to support our clients in the pharmaceutical, biotechnology, and medical device industries. You will be responsible for writing and reviewing clinical...
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Medical device QA/RA specialist
3 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics Copenhagen Full-time Salary Competitive 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 for a while and now you would like to work more holistically with every part of a QMS system. Maybe...
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Regulatory Compliance Specialist
24 hours ago
Copenhagen, Copenhagen, Denmark Kenvue Full timeJob DescriptionThe Senior Regulatory Affairs Specialist is responsible for ensuring regulatory compliance and securing approvals for new products, line extensions, and additional claims. They will manage the coordination and submission of regulatory applications for drugs, cosmetics, medical devices, and similar products.This role requires strong knowledge...
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Medical Device Quality Assurance Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics Copenhagen is seeking a highly skilled QA/RA specialist to join our Clinical and Regulatory team. As a key member of our team, you will play a central role in maintaining superior product quality and expanding our presence in new markets.This temporary consultancy position requires a seasoned QA/RA expert with a flair for product quality and...
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Regulatory Affairs Lead
18 hours ago
Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full timeJob SummaryThis role is an excellent opportunity for a seasoned Regulatory Affairs professional to lead regulatory projects both locally and globally. The ideal candidate will have a strong background in regulatory compliance, excellent communication skills, and the ability to work effectively in a fast-paced environment.The selected candidate will be...
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Copenhagen, Copenhagen, Denmark European Federation Of Organizations For Medical Physics - EFOMP Full time**Job Overview**The ideal candidate will possess most of the following qualifications:M.Sc. degree or higher, preferably within biomedical or electrical engineeringExperience working with QA/QC for medical devicesExperience with mixed technology productsDocumented expertise in main standards governing medical device development and production, such as MDR,...
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Regulatory Affairs Manager
3 days ago
Copenhagen, Copenhagen, Denmark Norgine Full timeKey ResponsibilitiesThe Quality Compliance Officer will be responsible for:Ensuring compliance with regulatory requirements.Performing delegated duties concerning regional Wholesale Distribution licences.Maintaining Norgine's Nordics quality management systems.Supporting successful regulatory inspections.Generating regional metrics.Contributing to risk...
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Senior Device Development Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeAchieve extraordinary results as a Senior Design Control Specialist in our Device Development team.At Ascendis Pharma A/S, we are dedicated to making a meaningful difference in patients' lives through the development of new and potentially best-in-class therapies. Our TransCon technology enables us to build a leading, fully integrated biopharmaceutical...
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Copenhagen, Copenhagen, Denmark European Federation Of Organizations For Medical Physics - EFOMP Full timeCompany OverviewWe are a dynamic and globally oriented business that is expanding our organization around the product X1 CBCT unit. Our team is dedicated to bringing CBCT scanning to the next level by enabling true motion correction and high fidelity scanning to clinics across the world.We pride ourselves on providing an opportunity for the industry's best...
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Clinical Documentation Consultant
3 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeClinical Documents SpecialistWe are looking for a skilled Clinical Documents Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6, integrated summaries of...
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Regulatory Affairs Scientist
2 days ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAbout UsC. H. Lundbeck A/S is a leading global pharmaceutical company that has been active in the production of drugs for more than 70 years. Our main goal is to develop and commercialize treatments for brain diseases. We are committed to delivering innovative treatments to patients around the world.Job DescriptionWe are seeking a highly skilled Senior...
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Senior Consultant
2 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeAbout the RoleThe ideal candidate for this position holds at least 10 years of experience within drug development in the pharma/biotech industry, with at least 5 years of experience in medical writing. Understanding of international regulations, ICH guidelines, and document preparation and production (CTDs) is required.A strong understanding of clinical...