Regulatory Affairs and Quality Management Lead
Vor 2 Tagen
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.
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