Regulatory Affairs/ Cybersecurity Consultant

Employ me for

Regulatory Affairs
✔ Development of a regulatory strategy (approval roadmap for FDA and EU-MDR)
✔ Support & review of technical documentation according to MDR
✔ Qualification and classification of your medical devices (MDR and IVDR) ✔ Validation plan according to MDR Annex I
✔ Support with MDR approvals and conformity assessment
✔ ISO 14971 risk management
✔ ISO 62304 software development lifecycle
✔ Literature research for clinical evaluation
✔providing market access strategie

 Cybersecurity
✔ Conducting penetration tests for medical devices
✔ Development of security concepts for MDR compliance
✔ Support with the Secure Development Life Cycle
✔ Thread modeling and development of software architectures
✔ Creation of cybersecurity documentation for regulatory authorities
✔ ISO 81001-5-1: Risk management for cyber risks
✔ Cyber Riskmanagement according NIS-2, ISO 27001,
✔ Secure development of networked or digital products: Cyber ​​Resilience Act

✅ Quality management and business development
✔ Introduction & optimization of ISO 13485 and ISO 9001 Quality management systems
✔ Review of documentation and processes
✔ Preparation for your next audit and GAP analysis
✔ Education, training and personnel qualification
✔ Workshops and training courses to build company competencies
✔ Process management and improving team efficiency
✔ Agile project management
✔ Support in working with notified bodies and authorities  

 
Langjährige Erfahrung in Regulatory Affairs (RA), Qualitätsmanagement & Cybersecurity (CS)

Gerne teile ich meine Expertise aus renommierten Beratungsunternehmen und RA-Management-Positionen aus der Medizintechnik (von KMU bis Global Playern)

Spezialisiert auf schnelle & pragmatische Lösungen für Start-ups & KMUs


Studium:

B.Sc: Medizinisches Management

M.Sc: Digitale Medizin (RA. Management)

Erfahrung:

✅Regulatory Affairs: >3 Jahre
✅Qualitätsmanagement: >3 Jahre
✅Cybersecurity: >1 Jahr