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Skills
Medical Device Expert
Usability Expert IEC 62366
Risk Manager ISO 14971
SCRUM Product Owner
Clinical Consultant
A versatile, results-oriented professional with years of extensive experience in risk management, usability engineering, medical care and clinical consulting who enjoys the challenge of finding creative and resilient solutions in the highly regulated environment of medical device development. High level of technical understanding leads to his profound knowledge of the medical device being developed. Has a broad clinical background and approaches all aspects of the job with an open mind and great willingness to learn. Gladly and competently passes on acquired knowledge. Analytical thinking, sense of responsibility and initiative, coupled with own problem-solving skills and the ability to deal openly and constructively with conflicts within the team. Makes decisions or can competently contribute to them. Has a high degree of stress resistance, control ability, persuasiveness, and assertiveness.
CORE COMPETENCIES:
Risk Management, ISO 14971, IEC 62304 & Usability Engineering, IEC 62366 & Agile Project Management & Train the trainer & Team Leadership & Solutions Advice & Communication & System Requirement Specification & Business Development
Projekthistorie
04/2024
-
bis jetzt
Regulatrory Affairs Consultant
Software Development Provider
(Pharma und Medizintechnik, 250-500 Mitarbeiter)
Assessment for MDR Regulation; App for medical study support
Review of the risk management file
Review of verification and validation reports
Review of software development documentation
Review of the usability file