Utimacos Information Security
Senior Certification Specialist(m/w/x)
Vollzeitmit HomeofficeSenior
Aachen, Düsseldorf, Neu-Isenburg
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
SOSolventum
Regulatory Affairs Manager for Medical Software, Cybersecurity & AI/Digital Health(m/w/x)
Vollzeitmit HomeofficeManagement
AI/ML
Nejo KI-Zusammenfassung
Global regulatory strategy development for medical software, cybersecurity, and AI/digital health. Bachelor's degree in a technical field and significant medical device software regulatory affairs experience required. Partnering with cross-functional teams, including R&D and Product Security.
Deine Match-Analyse
von deinem Karriere-Agenten
Warum dieser Job zu dir passt
Mögliche Lücken
Tipps für deine Bewerbung
Anforderungen
- Bachelor's Degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, Information Technology, Regulatory Affairs, or related scientific/technical discipline
- Significant experience in Medical Device Regulatory Affairs supporting software-containing medical devices, medical device software, or SaMD
- Experience developing regulatory strategies and submissions for embedded/stand-alone medical software
- Working knowledge of medical device software and cybersecurity expectations
- Practical familiarity with key software, cybersecurity, risk management, and quality system standards/guidance
- Ability to work independently
- Fluent English and German language skills
- Advanced degree in Regulatory Affairs, Computer Science, Software Engineering, Biomedical Engineering, Cybersecurity, or related technical discipline
- Certification or formal training in AI/ML, cybersecurity, secure software development, regulatory affairs, or quality systems
- Experience interpreting and applying EU AI Act, EU Cyber Resilience Act, FDA AI/ML expectations, GMLP, and global digital health/software regulatory frameworks
- Strong executive communication, training, and presentation skills
- Proficiency with MS Office/Microsoft 365 tools
- Legally authorized to work in country of employment without sponsorship
Aufgaben
- Serve as regulatory subject matter expert for medical software, cybersecurity, and AI
- Partner with Regulatory Affairs, R&D, Software Engineering, Product Security, Quality, Clinical, and Product teams
- Ensure regulatory requirements are integrated into product strategy, development, submissions, and post-market lifecycle
- Develop and implement global regulatory strategies and submissions for medical device software and digital health software
- Ensure compliance with EMEA and global regulatory and standards requirements for medical software
- Compile and review regulatory dossiers and technical documentation
- Manage software risk management, verification and validation evidence, cybersecurity documentation, and AI-related documentation
- Support quality management system processes for software lifecycle, design controls, risk management, cybersecurity, change control, complaint handling, vigilance, and post-market surveillance
- Communicate with authorities, notified bodies, consultants, distributors, and internal stakeholders
- Process country-specific requests for global marketing authorizations
- Support bid and tender submissions
- Provide training on software, cybersecurity, AI, and digital health regulatory requirements
- Conduct regulatory intelligence assessments and practical interpretations for cross-functional teams
Berufserfahrung
ca. 4 - 6 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – fließend
Deutsch – fließend
Tools & Technologien
IEC 62304IEC 82304-1IEC 81001-5-1ISO 14971ISO 13485FDA software guidanceFDA cybersecurity guidanceEU MDR/MDCG software guidanceAI/digital health frameworksEU AI ActEU Cyber Resilience ActFDA AI/MLGood Machine Learning PracticeMS OfficeMicrosoft 365
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Solventum erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei SolventumÜber das Unternehmen
SO
HealthcareDüsseldorf
Das Unternehmen ist ein junges Gesundheitsunternehmen, das innovative Lösungen an der Schnittstelle von Gesundheit, Material- und Datenwissenschaft entwickelt.
solventum.comWie gut ist dein Lebenslauf?
Nejo bewertet ihn, und bringt ihn danach gemeinsam mit dir in Bestform.
Du hast noch keinen Lebenslauf?
Noch nicht perfekt?
- Utimacos Information SecuritySenior Certification Specialist(m/w/x)Vollzeitmit HomeofficeSeniorAachen, Düsseldorf, Neu-Isenburg
- Karo HealthcareScientific Affairs Specialist - Central Europe (German-speaking)(m/w/x)Vollzeitmit HomeofficeBerufserfahrenDüsseldorf
- MCC Medical CareCapital GmbHMitarbeiter Risikomanagement & Regulatorik(m/w/x)Vollzeit/Teilzeitmit HomeofficeBerufserfahrenKrefeld
- Medtronic. Marketing Manager – Neurovascular(m/w/x)Vollzeitmit HomeofficeSeniorMeerbuschab 89.440 - 141.600 / Jahr