Regulatory Affairs Expert in Radiology Software

Job Summary:We are seeking a highly skilled Quality and Regulatory Affairs Consultant to join our Clinical and Regulatory team. The ideal candidate will have a strong background in quality assurance and regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest quality standards and...

Job Description:We are looking for a Regulatory Affairs Expert for Medical Devices to join our Clinical and Regulatory team. The ideal candidate will have a strong background in regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest regulatory standards and that we comply with...

This is an excellent opportunity for someone who is passionate about quality and regulatory affairs to join a leading company in the medical device industry. As a QA/RA specialist, you will be responsible for ensuring compliance with regulatory requirements, including MDR and ISO 13485, and will have the opportunity to work on a wide range of projects, from...

About the RoleAt Genmab, we're pushing the boundaries of antibody therapies to transform lives. As a Director/Associate Director, Global Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy for biologics.This exciting opportunity requires a seasoned professional with expertise in CMC regulatory affairs, strategic thinking, and...

Radiometer Danmark/Danaher is proud to work at the forefront of diagnostic innovation. Our shared purpose unites over 4000 employees worldwide in a pursuit to improve patient care through technology and solutions.We are seeking an exceptional individual to join our Global Regulatory Affairs team as Senior Manager, RA Processes, Systems and Tools.As part of...

Radiobotics ApS is a pioneering company in the field of medical devices, committed to solving 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.We are seeking a Regulatory Affairs Consultant for...

We are looking for a Senior Regulatory Expert to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for implementing and optimizing our new Submission Publishing Tool. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory...

Get AI-powered advice on this job and more exclusive features. Senior Business Development Consultant at Black Swans Exist Director of Regulatory Affairs Are you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health,...

Black Swans Exist, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a seasoned Director of Regulatory Affairs to spearhead their global regulatory strategies.About the RoleIn this high-impact position, you will drive the development and approval of innovative biologics, combination drug-device...

About the JobPandora A/S is seeking a highly motivated and experienced Regulatory Affairs Director to lead our global regulatory affairs function. As a key member of our team, you will be responsible for ensuring that we maintain the highest standards of regulatory compliance and integrity.Main ResponsibilitiesDevelop and implement effective regulatory...

Job 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...

We are seeking a highly experienced Regulatory Publisher & Submission Manager to join our Regulatory Affairs Team in Copenhagen or Malta.As a key member of our team, you will be responsible for:Regulatory publishing: compiling, formatting, and validating regulatory submissions in eCTD.System implementation: playing a key role in the implementation of our new...

We are looking for an exceptional individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring regulatory compliance and oversight for our clinical trials.In this role, you will represent RA in Clinical Trial Teams and...

We are seeking a skilled and experienced Regulatory Affairs Director to join our team at Genmab A/S. As a key member of our Regulatory Affairs CMC team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of...

We are looking for a new colleague to join our Regulatory department. Oresund Pharma is seeking a dedicated and experienced Regulatory Affairs Manager; in this role you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a product portfolio following regulatory requirements and commercial demands. As a...

About the RoleWe are seeking an experienced Global Regulatory Affairs Project Lead to join our team in Copenhagen, Denmark. In this role, you will be responsible for leading the development and execution of the EU/ROW regulatory strategy for assigned projects.Key ResponsibilitiesAct as EU/ROW regulatory lead and EMA contact person for assigned...

At Macure Pharma, we are seeking a seasoned Regulatory Affairs Specialist to join our team. This role offers an exciting opportunity to shape regulatory processes in a fast-growing company and play a key role in the implementation of our new Submission Publishing Tool.Key Responsibilities:Compiling, formatting and validating regulatory submissions in eCTD...

Job 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...

About RadiometerRadiometer is a leading manufacturer of in vitro diagnostic instruments and consumables, dedicated to improving global healthcare through reliable, fast, and easy patient diagnoses. Our vision is to improve patient lives by making accurate diagnoses possible.As a key member of our team, you will be responsible for driving process improvements...

About the Role:The Associate Director Regulatory Strategy will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. This role will represent EU/ROW in the Global Regulatory Team(s) and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Develop...