Regulatory Affairs and Quality Assurance Specialist

vor 11 Stunden


Hamburg, Hamburg, Deutschland apoqlar Vollzeit
About Us

ApoQlar is a pioneering medical technology company that revolutionizes the healthcare industry by leveraging cutting-edge technology and innovative solutions.

Job Overview

We are seeking an experienced Regulatory Affairs and Quality Assurance Specialist 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 mixed reality platform complies with regulatory and statutory requirements.

Responsibilities
  • Develop and implement a regulatory strategy to ensure compliance with applicable laws and regulations.
  • Maintain and optimize our Quality Management System (QMS) and Regulatory Affairs framework.
  • Lead global regulatory approval processes and respond to questions from notified bodies and regulators.
  • Implement regulatory requirements in accordance with EU MDR 2017/745.
  • Manage risk management activities and collaborate with the risk management team.
  • Participate in and support internal and external audits.
Requirements
  • University degree in biomedical science, engineering, pharmacy, or a related field.
  • At least 7 years of experience in regulatory affairs and quality management, including FDA submissions.
  • Proficient knowledge of EU medical device regulations and ISO 13485.
  • Experience in communication with authorities and notified bodies.
  • In-depth knowledge of software lifecycle processes and IEC 62304.
  • Strong analytical skills and ability to evaluate product compliance.
Why Work With Us
  • Opportunity to work with new and exciting technologies.
  • Chance to positively impact the lives of patients, students, and surgeons worldwide.
  • Competitive compensation structure and opportunities for growth.


  • Hamburg, Hamburg, Deutschland Sidekick Health Germany Vollzeit

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Sidekick Health Germany. As a Quality Assurance Specialist, you will be responsible for ensuring the implementation, monitoring, and continuous improvement of our quality management system, ensuring that our products meet the highest standards and fulfill all legal...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    Job SummaryWe are seeking a highly motivated and detail-oriented Regulatory Affairs Coordinator to join our team at Olympus. As a Regulatory Affairs Coordinator, you will assist in the preparation, review, and organization of regulatory documents required for submissions, including technical files, product registration dossiers, and labeling.Key...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    About 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...


  • Hamburg, Hamburg, Deutschland apoqlar Vollzeit

    Transformative 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,...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    About 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...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    Key ResponsibilitiesAs a Regional Quality Assurance Specialist at Olympus, you will be responsible for preparing, negotiating, and executing regional and local quality assurance agreements on behalf of the company. Your goal will be to ensure that Olympus commitments are met in all sites.Collaboration and LeadershipYou will work closely with procurement and...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    Key ResponsibilitiesAs a Regulatory Affairs Specialist at Olympus, you will lead the development and implementation of regulatory strategies for product registrations in the Asia Pacific and China regions. You will collaborate with cross-functional teams to ensure alignment with business objectives and regulatory requirements.Key Responsibilities...


  • Hamburg, Hamburg, Deutschland Sidekick Health Germany Vollzeit

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Sidekick Health Germany. As a Quality Assurance Specialist, you will be responsible for implementing, monitoring, and continuously improving our quality management system to ensure our products meet the highest standards and comply with all relevant laws,...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    About the RoleOlympus is seeking a highly motivated and detail-oriented Working Student to support our Regulatory Affairs team. 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...


  • Hamburg, Hamburg, Deutschland apoqlar Vollzeit

    Join 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...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    About the RoleWe are seeking a highly motivated and organized 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...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    About the RoleWe are seeking a highly motivated and organized 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...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    Key ResponsibilitiesAs a Regional Quality Assurance Specialist at Olympus, you will be responsible for preparing, negotiating, and executing regional and local quality assurance agreements on behalf of the company. Your goal will be to ensure that Olympus commitments are met in all sites.Collaboration and LeadershipYou will work closely with procurement and...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    Key ResponsibilitiesOlympus is seeking a highly skilled Regulatory Affairs Manager to lead the development and implementation of regulatory strategies for product registrations in the Asia Pacific region and China. The ideal candidate will have a strong background in regulatory affairs and experience in leading cross-functional teams.Key...


  • Hamburg, Hamburg, Deutschland AERO HighProfessionals Vollzeit

    Quality Assurance SpecialistAERO HighProfessionals is seeking a Quality Assurance Specialist to join our team in the aerospace industry. As a Quality Assurance Specialist, you will be responsible for managing supply chain and quality aspects of contracts, ensuring suppliers are compliant with certifications required in coordination with relevant...


  • Hamburg, Hamburg, Deutschland Olympus Vollzeit

    Job 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...


  • Hamburg, Hamburg, Deutschland Centrica Vollzeit

    Job Title: Regulatory Affairs ManagerWe are Centrica, a leading energy company revolutionising a cleaner, greener future. As a Regulatory Affairs Manager, you will play a vital role in shaping our energy trading, origination, and asset management activities in Germany and beyond.About the Role:As a key member of our team, you will be responsible for...


  • Hamburg, Hamburg, Deutschland Centrica Vollzeit

    Job Title: Regulatory Affairs ManagerWe are Centrica, a leading energy company revolutionising a cleaner, greener future. As a Regulatory Affairs Manager, you will play a vital role in shaping our energy trading, origination, and asset management activities in Germany and beyond.About the Role:As a key member of our team, you will be responsible for...


  • Hamburg, Hamburg, Deutschland apoqlar Vollzeit

    Join 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...


  • Hamburg, Hamburg, Deutschland apoqlar Vollzeit

    Join 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...