Aktuelle Jobs im Zusammenhang mit Regulatory Affairs and Quality Management Lead - Hamburg, Hamburg - apoqlar
-
Regulatory Affairs and Quality Management Lead
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and Quality Management LeadAt apoQlar, we're revolutionizing the healthcare industry with cutting-edge medical mixed reality technology. As a Regulatory Affairs and Quality Management Lead, you'll play a crucial role in ensuring our platform meets regulatory and statutory requirements.About the Role:Develop and lead the...
-
Regulatory Affairs and Quality Management Lead
vor 4 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
-
Regulatory Affairs and Quality Management Lead
vor 4 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
-
Regulatory Affairs and Quality Management Lead
vor 3 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
-
Regulatory Affairs and Quality Management Lead
vor 3 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
-
Regulatory Affairs and Quality Management Lead
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:Apoqlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the healthcare industry. Our flagship product, VSI HoloMedicine, is a medically certified software...
-
Regulatory Affairs and Quality Management Lead
vor 1 Monat
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
-
Regulatory Affairs and Quality Management Lead
vor 1 Monat
Hamburg, Hamburg, Deutschland apoqlar VollzeitJoin Our Team as a Regulatory Affairs and QMS LeadMake a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.About Us:ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the way medicine is practiced, experienced, learned, and shared. Our flagship product, VSI...
-
Regulatory Affairs and Quality Management Lead
vor 1 Woche
Hamburg, Hamburg, Deutschland apoqlar VollzeitTransforming Healthcare with Medical Mixed RealityAbout Us:Apoqlar is a pioneering developer of medical mixed reality technology, revolutionizing the healthcare industry with cutting-edge solutions. Our flagship product, VSI HoloMedicine, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform medical images,...
-
Regulatory Affairs and Quality Management Lead
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitTransforming Healthcare with Cutting-Edge TechnologyApoqlar is a pioneering medical technology company that is revolutionizing the healthcare industry with its innovative mixed reality platform. We are seeking a highly skilled Regulatory Affairs and Quality Management Lead to join our team in Hamburg.About the RoleThe successful candidate will be responsible...
-
Regulatory Affairs and Quality Management Lead
vor 1 Woche
Hamburg, Hamburg, Deutschland apoqlar VollzeitMake a Positive Impact in the Global Healthcare CommunityAbout Us: apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform...
-
Regulatory Affairs and Quality Management Lead
vor 1 Woche
Hamburg, Hamburg, Deutschland apoqlar VollzeitMake a Positive Impact in the Global Healthcare CommunityAbout Us: apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform...
-
Hamburg, Hamburg, Deutschland apoqlar VollzeitTransformative Opportunity in Medical Mixed RealityAbout Us: apoQlar is a pioneering developer of a medical mixed reality platform that is revolutionizing healthcare practices, education, and experiences. Our flagship product, VSI HoloMedicine, is a medically certified software platform leveraging the Microsoft HoloLens hardware to transform medical images,...
-
Regulatory Affairs and Quality Management Expert
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitTransform the Future of Healthcare with apoQlarAbout Us:ApoQlar is a pioneering medical technology company that is revolutionizing the healthcare industry with its cutting-edge medical mixed reality platform, VSI HoloMedicine. Our platform leverages the Microsoft HoloLens hardware to transform medical images, clinical workflows, and medical education into an...
-
Regulatory Affairs Director
vor 2 Wochen
Hamburg, Hamburg, Deutschland Olympus VollzeitJob SummaryOlympus is seeking an experienced Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key Responsibilities:Lead and manage...
-
Regulatory Affairs Director
vor 1 Woche
Hamburg, Hamburg, Deutschland Olympus VollzeitJob SummaryOlympus is seeking an experienced Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key Responsibilities:Lead and manage...
-
Regulatory Affairs Director
vor 1 Woche
Hamburg, Hamburg, Deutschland Olympus VollzeitKey Responsibilities:We are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key...
-
Senior Regulatory Affairs Manager
vor 3 Wochen
Hamburg, Hamburg, Deutschland Olympus VollzeitJob SummaryWe are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key...
-
Senior Regulatory Affairs Manager
vor 1 Monat
Hamburg, Hamburg, Deutschland Olympus VollzeitAbout the RoleWe are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key...
-
Senior Regulatory Affairs Manager
vor 1 Monat
Hamburg, Hamburg, Deutschland Olympus VollzeitAbout the RoleWe are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.Key...
Regulatory Affairs and Quality Management Lead
vor 2 Monaten
We are seeking a highly skilled Regulatory Affairs and Quality Management Lead to join our team at apoQlar. As a key member of our Regulatory & Quality Management team, you will play a leading role in ensuring our medical mixed reality platform is in compliance with regulatory and statutory requirements.
Key Responsibilities- Develop and Lead Regulatory Strategy: Collaborate with C-Level and engineering teams to develop and implement a comprehensive regulatory strategy that ensures compliance with applicable laws and regulations.
- Maintain and Optimize QMS: Develop and maintain a Quality Management System (QMS) that meets regulatory requirements, focusing on processes such as change control, design controls, verification and validation, and risk management.
- Lead Regulatory Approval Processes: Oversee the regulatory approval processes globally, ensuring timely and efficient certification of new product developments.
- Develop Regulatory Responses: Lead the development of regulatory responses to questions from notified bodies, global regulators, and regulatory representatives.
- Implement Regulatory Requirements: Ensure compliance with EU MDR 2017/745 and other regulatory requirements.
- Lead Risk Management Activities: Collaborate with the risk management team to identify, assess, and mitigate risks associated with medical device software.
- Participate in Audits: Participate in and support external and internal audits, ensuring compliance with regulatory requirements.
- Ensure Compliance: Ensure that all regulatory procedures are up-to-date and compliant with new regulatory requirements.
- Monitor Regulatory Requirements: Stay up-to-date with new and revised regulatory requirements, standards, and guidance.
- Handle Serious Incidents: Handle serious incident and adverse event reporting in accordance with regulatory requirements.
- Ensure Effective Communication: Ensure effective communication with Notified Bodies and Regulatory Authorities.
- Ensure Marketing Compliance: Ensure that marketing communication is compliant with regulatory requirements.
- Act as PRRC: Act as the Person Responsible for Regulatory Compliance (PRRC).
- Education: University degree in biomedical science, engineering, pharmacy, or any other applied natural sciences.
- Experience: 7+ years of professional experience in regulatory affairs, including MDD/MDR and FDA submissions.
- Skills: Proficient knowledge of EU medical device regulations, Quality Management Systems, and software lifecycle processes.
- Language: Fluency in English is required, German is a plus.
ApoQlar is a developer of a medical mixed reality platform that is revolutionizing the healthcare industry. Our flagship product, VSI HoloMedicine, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform medical images, clinical workflows, and medical education into an interactive 3D mixed reality environment.
We are a multicultural and international team with offices in Miami, Poznan, Singapore, and Hamburg. We offer a flat hierarchy with direct access to the founding team and C-Level, high ownership, and the opportunity to drive projects forward.
