Aktuelle Jobs im Zusammenhang mit Regulatory Affairs and Quality Management Lead - Hamburg, Hamburg - apoqlar
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Regulatory Affairs and Quality Management Lead
vor 3 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...
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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...
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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...
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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 healthcare industry. Our flagship product, VSI HoloMedicine, is a medically certified software...
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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...
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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...
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Regulatory Affairs and Quality Management Lead
vor 2 Wochen
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,...
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Regulatory Affairs and Quality Management Lead
vor 3 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...
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Regulatory Affairs and Quality Management Lead
vor 2 Wochen
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...
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Regulatory Affairs and Quality Management Lead
vor 2 Wochen
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...
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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,...
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Regulatory Affairs and Quality Management Expert
vor 3 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...
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Regulatory Affairs Director
vor 3 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...
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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...
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Regulatory Affairs Director
vor 2 Wochen
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...
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Senior Regulatory Affairs Manager
vor 4 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...
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Senior Regulatory Affairs Manager
vor 2 Monaten
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...
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Senior Regulatory Affairs Manager
vor 2 Monaten
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...
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Senior Regulatory Affairs Manager
vor 4 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...
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Regulatory Affairs and QMS Director
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitTransform Medical Technology with Regulatory ExpertiseApoqlar is a pioneering medical technology company that is revolutionizing healthcare through cutting-edge mixed reality solutions. We are currently seeking an experienced Regulatory Affairs and QMS Lead to join our team in Hamburg. As a key member of our Regulatory & Quality Management team, you will...
Regulatory Affairs and Quality Management Lead
vor 2 Monaten
Make 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 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 global company with offices in Miami, Poznan, Singapore, and our headquarters in Hamburg. We are dedicated to leveraging cutting-edge technology and innovative solutions to revolutionize the healthcare industry.
We are currently seeking an enthusiastic and motivated individual to join our team in Hamburg (onsite/hybrid) as a Regulatory Affairs and QMS Lead. You will take a leading role within the Regulatory & Quality Management team and work closely with C-Level as well as our engineering teams to ensure our mixed reality platform is in compliance with regulatory and statutory requirements.
Responsibilities:- Develop and lead the regulatory strategy to ensure compliance with applicable laws, regulations, and ensure a fast and efficient certification of new product developments.
- Maintain and optimize the current QMS and RA framework, focusing on specific processes such as change control, design controls, verification and validation, and risk management.
- Lead the regulatory approval processes globally.
- Lead the development of regulatory responses for questions from notified bodies, global regulators, and regulatory representatives upon review of submissions in relation to the technical dossier.
- Implement regulatory requirements in accordance with EU MDR 2017/745.
- Lead risk management activities and work closely with the risk management team through the life cycle of medical device software.
- Participate in and support external/internal audits and responses to audit findings as appropriate.
- Ensure compliance with the current regulatory procedures and update the procedures when new regulatory requirements are determined.
- Monitor the new/revised applicable regulatory requirements, standards, guidance, and common specifications.
- Handle serious incident and adverse event reporting.
- Ensure that the communication with Notified Bodies and Regulatory Authorities is effective and that all the required information is provided.
- Ensure that marketing communication is according to regulatory requirements.
- Ensure that regulatory and statutory requirements are fully met across the whole organization.
- Ensure the promotion of awareness of applicable regulatory requirements throughout the organization.
- Act as appointed Person Responsible for Regulatory Compliance (PRRC).
- University degree in biomedical science, engineering, pharmacy, or any other applied natural sciences.
- 7+ years of professional experience including MDD/MDR and FDA submissions.
- Proficient practical FDA 510K application knowledge and a proven track record of associated products.
- Proficient knowledge of EU medical device regulations and Quality Management Systems for medical devices.
- Knowledge of MDSAP, ISO 13485, IEC 62304, and ISO.
- Experience in communication with authorities and notified bodies.
- In-depth knowledge of Software Lifecycle Processes, including expertise in implementing the requirements of the IEC 62304 standard and AAMI TIR45 guidance (agile).
- Extensive experience in Software as a Medical Device (SaMD), covering design controls, risk management, verification and validation, SOUP (Software of Unknown Provenance), and Software Configuration Management (SCM).
- Demonstrated ability to maintain and streamline QMS for seamless use across the organization, ensuring a sustainable and compliant system.
- Experience in communication with healthcare professionals.
- Strong analytical skills to evaluate product compliance and interpret regulatory guidelines.
- Ability to collaborate effectively with internal specialists and other external consultants (if required), ensuring alignment and cooperation.
- Experience in external and internal Audits.
- Fluency in English is a requirement, German is a huge plus.
- Chance to work with new and exciting technologies.
- Opportunity to positively impact the lives of patients, students, and surgeons around the world.
- Chance to not just shape but also create an entirely new market in healthcare using medical mixed reality.
- Work alongside a multicultural and international team – over 10 countries represented in our office.
- A flat hierarchy with direct access to the founding team and C-Level.
- High degree of ownership with the opportunity to drive projects forward on your own or with a team.
- Competitive compensation structure and ability to grow quickly within an advancing team.
Are you interested in helping us shape an entirely new market in healthcare and advancing next-generation medical technology? Then we look forward to hearing from you.
