Medical Device Regulatory Affairs Expert

We 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...

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...

We'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...

About 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...

Company 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...

Job 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...

Radiobotics 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...

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...

At 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...

Regulatory 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...

Job 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...

About Us">Radiobotics is a dynamic company that values innovation, integrity, and transparency. We strive to solve the global need for radiologists while ensuring every patient receives expert-level care.Our Mission">We aim to augment routine X-rays of the musculoskeletal system and enable non-specialists to report them assisted by our products. This will...

Job 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...

The 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...

At 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...

Innovative 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...

Job OverviewPharma IT is seeking a seasoned Senior/Principal Medical Writing Consultant to join our Regulatory Affairs & Medical Writing Team.The ideal candidate will have extensive experience in medical writing, with a strong understanding of international regulations and ICH guidelines.You will work as a consultant to support clients in the Pharma,...

Company 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...

Are 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...

Job OverviewWe are seeking a skilled QA/RA specialist to join our Clinical and Regulatory team. As a key member of our team, you will play a crucial role in maintaining superior product quality and taking lead on placing our products on new markets.Main Tasks:Defining and delivering on our strategy to maintain superior product qualityLeveraging your...