Clinical Reviewer MDR/IVDR(m/w/x)

Requirements

• University degree in medical or scientific studies or comparable professional knowledge
• 5+ years of relevant clinical experience
• Profound knowledge of regulations for certification of MD/IVD devices
• Multiple years of experience in evaluation and decision making for medical devices
• Strong interpersonal skills, self-starter, good decision-making and organizational skills
• Ability to manage multiple clinical evaluations and changing schedules
• Excellent communication skills (verbal and written)
• Strong conflict resolution skills
• Good command in German and English; any other European language is a benefit

Tasks

• Support the MD/IVD assessment team in clinical assessments
• Ensure assessments address regulatory responsibilities for clinical performance
• Formulate and improve clinical assessment procedures and protocols
• Develop and deliver training for clinical assessors
• Conduct periodic calibration events for the clinical team
• Assist the Head of Medical Regulatory Services in demonstrating effective assessment procedures
• Oversee and review clinical data assessments for compliance with regulations
• Support the Commercial team in estimating efforts for clinical assessments
• Represent CSA at congresses as a speaker on technical and clinical subjects

Work Experience

Education

Languages