Regulatory Affairs and Quality Management Lead
Vor 5 Tagen
Apoqlar 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 Responsibilities- Regulatory Strategy and Compliance: Develop and lead the regulatory strategy to ensure compliance with applicable laws, regulations, and standards.
- Quality Management System (QMS) Maintenance: 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.
- Regulatory Approvals: Lead the regulatory approval processes globally, ensuring timely and efficient certification of new product developments.
- Regulatory Communication: 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.
- EU MDR Compliance: Implement regulatory requirements in accordance with EU MDR 2017/745.
- Risk Management: Lead risk management activities and work closely with the risk management team through the life cycle of medical device software.
- Audits and Compliance: Participate in and support external/internal audits and responses to audit findings as appropriate.
- Regulatory Procedures: Ensure compliance with the current regulatory procedures and update the procedures when new regulatory requirements are determined.
- Regulatory Monitoring: Monitor new/revised applicable regulatory requirements, standards, guidance, and common specifications.
- Incident Reporting: Handle serious incident and adverse event reporting.
- Regulatory Awareness: Ensure that the communication with Notified Bodies and Regulatory Authorities is effective and that all the required information is provided.
- Marketing Compliance: Ensure that marketing communication is according to regulatory requirements.
- Regulatory Compliance: Ensure that regulatory and statutory requirements are fully met across the whole organization.
- Regulatory Training: Ensure the promotion of awareness of applicable regulatory requirements throughout the organization.
- PRRC: Act as appointed 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 including MDD/MDR and FDA submissions.
- Regulatory Knowledge: Proficient practical FDA 510K application knowledge and a proven track record of associated products.
- EU Medical Device Regulations: Proficient knowledge of EU medical device regulations and Quality Management Systems for medical devices.
- MDSAP, ISO 13485, IEC 62304, and ISO 14971: Knowledge of MDSAP, ISO 13485, IEC 62304, and ISO 14971.
- Communication: Experience in communication with authorities and notified bodies.
- Software Lifecycle Processes: In-depth knowledge of Software Lifecycle Processes, including expertise in implementing the requirements of the IEC 62304 standard and AAMI TIR45 guidance (agile).
- Software as a Medical Device (SaMD): 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).
- QMS Maintenance: Demonstrated ability to maintain and streamline QMS for seamless use across the organization, ensuring a sustainable and compliant system.
- Communication with Healthcare Professionals: Experience in communication with healthcare professionals.
- Analytical Skills: Strong analytical skills to evaluate product compliance and interpret regulatory guidelines.
- Collaboration: Ability to collaborate effectively with internal specialists and other external consultants (if required), ensuring alignment and cooperation.
- External and Internal Audits: Experience in external and internal audits.
- Language Skills: Fluency in English is a requirement, German is a huge plus.
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 medical images, clinical workflows, and medical education into an interactive 3D mixed reality environment.
We are a multicultural and international team with over 10 countries represented in our office. We offer a flat hierarchy with direct access to the founding team and C-Level, high degree of ownership, and competitive compensation structure.
Join us in shaping an entirely new market in healthcare and advancing next-generation medical technology.
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