Utimacos Information Security
Senior Certification Specialist (m/w/x)
Vollzeitmit HomeofficeSenior
Aachen, Düsseldorf, Neu-Isenburg
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SOSolventum
Regulatory Affairs Program Manager for Medical Software, Cybersecurity & AI/Digital Health (m/w/x)
Vollzeitmit HomeofficeSenior
AI/ML
Nejo KI-Zusammenfassung
Developing global regulatory strategies and submissions for digital health software, securing CE marking. Medical device software and cybersecurity experience required. 4 weeks vacation, company car for private use.
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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 software as medical device
- 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 a regulatory SME for software and medical devices
- Ensure regulatory requirements are built into product lifecycle
- Develop and implement global regulatory strategies and submissions for digital health software
- Secure CE marking and global market access
- Ensure compliance with EMEA and global medical software regulations
- Ensure compliance with software quality system expectations
- Compile and review regulatory dossiers and technical documentation
- Support quality management system processes for the product portfolio
- Communicate with authorities and stakeholders on requests
- Support bid and tender submissions
- Provide training on software, cybersecurity, AI, and digital health regulations
- Conduct regulatory intelligence assessments
- Interpret regulatory requirements for cross-functional teams
Berufserfahrung
ca. 4 - 6 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Deutsch – fließend
Englisch – fließend
Tools & Technologien
MS OfficeMicrosoft 365
Benefits
Attraktive Vergütung
- Competitive pay
Sonstige Vorteile
- Competitive benefits
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