Medical Device Quality Assurance and Regulatory Affairs Specialist

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...

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...

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...

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...

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...

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...

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...

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...

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...

Job Summary">As a Quality Assurance and Regulatory Affairs Specialist, you will play a vital role in ensuring the quality and regulatory compliance of our medical devices. Your primary responsibilities will include defining and delivering our strategy to maintain superior product quality, taking lead on placing our products on new markets, and becoming an...

In 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...

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...

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...

About 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...

At [Company Name], we are committed to delivering high-quality medical devices that meet or exceed customer expectations. As a Quality Management System Specialist, you will be responsible for developing and implementing effective quality management systems to ensure compliance with regulatory requirements.You will work closely with cross-functional teams to...

Join 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...

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...

Required Skills and QualificationsYou must have at least 1 year of experience within quality assurance and/or regulatory affairs. You should also have strong knowledge of quality management systems and regulatory requirements within MDR and ISO 13485.Qualifications:A master's degree in healthcare, medical or life science is preferredA positive can-do...

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 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...