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3.783,3€ pro Monat
...Erfahrung mit allgemeinen regulatorischen Anforderungen (z. B. NIS2, DSGVO). Kenntnisse von sektorspezifischen Vorgaben (z.B. GTelG, MDR) von Vorteil. Fundierte Kenntnisse in Informationssicherheits-Frameworks (z.B. ISO/IEC 2700x, BSI IT-Grundschutz) Methodenkompetenz...EmpfohlenVollzeitAusbildungsplatzSelbständige TätigkeitWeiterbildungFlexible Arbeitszeit45.000€ pro Jahr
...standardized skin imaging and AI-powered skin analysis. In this on-site role, you will ensure compliance with cybersecurity standards (MDR, FDA, ISO 27001/13485, IEC 62443/62304), implement and maintain security controls, manage risk and incident response, and support...EmpfohlenVollzeitAusbildungsplatz3.783€ pro Monat
...Erfahrung mit allgemeinen regulatorischen Anforderungen (z. B. NIS2, DSGVO). Kenntnisse von sektorspezifischen Vorgaben (z.B. GTelG, MDR) von Vorteil. Erfahrungen und Kenntnisse des IT Betriebs in Gesundheitseinrichtungen von Vorteil. Ausbildung ~ Abgeschlossenes...EmpfohlenVollzeitAusbildungsplatzSelbständige TätigkeitHomeoffice50.000€ pro Jahr
.... Responsible to ensure that assigned medical device and combination product development projects are in compliance to IEC 62304, MDR, ISO 13485, ISO 14971, and other relevant global regulations and international standards. Provides DQ technical quality support for...EmpfohlenVollzeitAusbildungsplatz- ...execute usability engineering activities for new and existing medical hardware devices in accordance with regulatory requirements (e.g. MDR FDA IEC 62366-1 IEC). Develop and maintain usability engineering files including user research plans use specifications user...EmpfohlenHomeoffice
- ...risks exploitation patterns and protection requirements for modern digital systems. Evaluate cybersecurity assurance concepts (SOC/MDR models forensics approaches vulnerability discovery penetration testing resilience validation) for relevance and feasibility....EmpfohlenVollzeitPhD PositionRemote
- ...Your responsibilities: You co-develop new algorithms for our diabetes companion app and support in the certification process under MDR/FDA to launch them as product features - in close collaboration with the other science and product stakeholders. You take on a...EmpfohlenVollzeitRemote
- ...and operational excellence. Maintain and enhance Quality Management System (QMS) infrastructure and ensure adherence to ISO 13485, MDR and FDA requirements. Support continuous improvement initiatives and risk management processes with a hands-on technical approach....Empfohlen
- ...~ Requirements-engineering experience preferred but not mandatory ~ Experience with medical-device regulations preferred (e.g. MDR FDA) ~ Product- or Program-Management background preferred but not mandatory ~ Technical aptitude with a clinical/hospital background...EmpfohlenVollzeitSchulungHomeofficeInternationale Firmen
- ...Management preferably in the medical device sector (ISO 13485) or any industry with high regulatory standards. Knowledge of EU MDR (Medical Device Regulation) and experience with Class II or higher medical devices is an advantage. Familiarity with clinical...EmpfohlenVollzeitUnbefristete ArbeitSchulungRemote