Regulatory Affairs and Quality Management Lead
Vor 7 Tagen
Join our team in shaping the future of healthcare
Apoqlar is a pioneering medical technology company that is revolutionizing the healthcare industry with cutting-edge medical mixed reality technology. Our flagship product, VSI HoloMedicine, leverages 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 Hamburg, Miami, Poznan, and Singapore, dedicated to delivering innovative solutions and making a positive impact in the global healthcare community.
About the Role
- Develop and lead regulatory strategy for compliance with laws and regulations
- Maintain and optimize current QMS and RA framework
- Lead regulatory approval processes globally
- Develop regulatory responses for questions from regulators
- Implement regulatory requirements according to EU MDR
- Lead risk management activities
- Participate in audits and responses to findings
- Ensure compliance and update procedures as needed
- Monitor new regulatory requirements
- Handle incident and event reporting
- Communicate effectively with Notified Bodies and Regulatory Authorities
- Promote awareness of regulatory requirements throughout the organization
- Act as Person Responsible for Regulatory Compliance
Requirements
- University degree in biomedical science, engineering, pharmacy, or related field
- 7+ years of experience in MDD/MDR and FDA submissions
- Knowledge of EU medical device regulations and QMS
- Experience with Software as a Medical Device (SaMD)
- Strong analytical and communication skills
- Fluency in English, German is a plus
What We Offer
- Work with cutting-edge technologies
- Impact the lives of patients, students, and surgeons worldwide
- Shape the future of healthcare with medical mixed reality
- Collaborate with a diverse international team
- Direct access to the founding team and C-Level
- Owning projects and driving them forward
- Competitive compensation and growth opportunities
-
Regulatory Affairs and Quality Management Lead
Vor 4 Tagen
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleWe 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 ResponsibilitiesDevelop and Lead...
-
Regulatory Affairs and Quality Management Lead
Vor 4 Tagen
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleWe 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 ResponsibilitiesDevelop and Lead...
-
Regulatory Affairs and Quality Management Lead
vor 1 Woche
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleWe 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 ResponsibilitiesDevelop and Lead...
-
Regulatory Affairs and Quality Management Lead
Vor 2 Tagen
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleWe 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 ResponsibilitiesDevelop and Lead...
-
Regulatory Affairs and Quality Management Lead
vor 2 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleWe 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 ResponsibilitiesRegulatory Strategy...
-
Regulatory Affairs and Quality Management Lead
Vor 5 Tagen
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleWe 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 ResponsibilitiesDevelop and Lead...
-
Regulatory Affairs and Quality Management Lead
Vor 5 Tagen
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleWe 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 ResponsibilitiesDevelop and Lead...
-
Regulatory Affairs and Quality Management Lead
Vor 2 Tagen
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleWe 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 compliant with regulatory and statutory requirements.Key ResponsibilitiesDevelop and lead the...
-
Regulatory Affairs and Quality Management Lead
Vor 2 Tagen
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleWe 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 compliant with regulatory and statutory requirements.Key ResponsibilitiesDevelop and lead the...
-
Regulatory Affairs and Quality Management Lead
vor 1 Woche
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleApoqlar is seeking a highly skilled Regulatory Affairs and Quality Management Lead to join our team in Hamburg. 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 ResponsibilitiesRegulatory...
-
Regulatory Affairs and Quality Management Lead
Vor 7 Tagen
Hamburg, Hamburg, Deutschland apoqlar VollzeitAbout the RoleApoqlar is seeking a highly skilled Regulatory Affairs and Quality Management Lead to join our team in Hamburg. 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 ResponsibilitiesRegulatory...
-
Strategic Regulatory Affairs Leader
vor 1 Woche
Hamburg, Hamburg, Deutschland CM Medical Recruitment VollzeitJob DescriptionCM Medical Recruitment is seeking an experienced and strategic Regulatory Affairs professional to lead and oversee the regulatory strategy and execution for a start-up in the structural heart device space.Key Responsibilities:Develop and implement global regulatory strategies to ensure timely approvals and market access for innovative...
-
Strategic Regulatory Affairs Leader
Vor 7 Tagen
Hamburg, Hamburg, Deutschland CM Medical Recruitment VollzeitJob DescriptionCM Medical Recruitment is seeking an experienced and strategic Regulatory Affairs professional to lead and oversee the regulatory strategy and execution for a start-up in the structural heart device space.Key Responsibilities:Develop and implement global regulatory strategies to ensure timely approvals and market access for innovative...
-
Senior Regulatory Affairs Manager
Vor 5 Tagen
Hamburg, Hamburg, Deutschland Olympus VollzeitAbout the RoleOlympus 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...
-
Senior Regulatory Affairs Manager
vor 1 Woche
Hamburg, Hamburg, Deutschland Olympus VollzeitAbout the RoleOlympus 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...
-
Regulatory Compliance and Quality Systems Manager
vor 4 Wochen
Hamburg, Hamburg, Deutschland apoqlar VollzeitBecome a part of our innovative teamAt apoQlar, we are committed to transforming the global healthcare landscape through advanced medical mixed reality solutions. Our pioneering platform, VSI HoloMedicine, utilizes state-of-the-art technology to enhance the way medical professionals engage with clinical data, educational resources, and patient care.We are...
-
Hamburg, Hamburg, Deutschland apoqlar VollzeitBecome a part of our innovative teamAt apoQlar, we are committed to transforming the global healthcare landscape through advanced medical mixed reality solutions. Our pioneering platform, VSI HoloMedicine, utilizes state-of-the-art technology to enhance the way medical professionals engage with clinical data, educational resources, and patient care.We are...
-
Regulatory Affairs Coordinator
Vor 2 Tagen
Hamburg, Hamburg, Deutschland Olympus VollzeitAbout the RoleWe are seeking a highly motivated and detail-oriented Working Student to join our Regulatory Affairs team at Olympus. As a key member of our team, you will assist in the preparation, review, and organization of regulatory documents required for submissions, including technical files, product registration dossiers, and labeling.Key...
-
Regulatory Affairs Coordinator
Vor 2 Tagen
Hamburg, Hamburg, Deutschland Olympus VollzeitAbout the RoleWe are seeking a highly motivated and detail-oriented Working Student to join our Regulatory Affairs team at Olympus. As a key member of our team, you will assist in the preparation, review, and organization of regulatory documents required for submissions, including technical files, product registration dossiers, and labeling.Key...
-
Regulatory Affairs Lead
vor 4 Wochen
Hamburg, Hamburg, Deutschland TCC GmbH VollzeitRegulatory Affairs ManagerTCC GmbH is at the forefront of telemedicine, leveraging advanced artificial intelligence to enhance digital intensive care medicine. We are seeking a **Regulatory Affairs Manager** to play a pivotal role in ensuring adherence to both national and international regulatory standards for our medical innovations.Key...
