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

Beschreibung

In this role, you will be integral to the clinical assessment process, ensuring compliance with regulations while developing training for assessors and improving assessment protocols. Your expertise will also be showcased at industry events, enhancing the presence in the field.

Anforderungen

• •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

Aufgaben

• •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

Benefits