Regulatory Technical Reviewer - Healthcare(m/w/x)

Anforderungen

• Bachelor’s degree in technical, medical, or scientific studies or comparable professional knowledge
• 5+ years of relevant experience in management system certification in medical devices
• Profound knowledge of regulations for certification of MD/IVD devices
• Profound knowledge of global medical device conformity assessment programs
• Multiple years of experience in evaluation and decision making for medical devices
• Qualification as management system auditor in healthcare sector
• Strong interpersonal skills, self-starter, good decision-making and organizational skills
• Technical competence to evaluate all products with assistance
• Ability to manage multiple assessments and changing schedules
• Demonstrates technical competence to review work of others
• Demonstrates technical competence in two or more technical scopes
• Excellent communication skills (verbal and written)
• Strong conflict resolution skills
• Good command in German and English; any other European language is a benefit
• Ability to travel as needed with short notice (up to 15% travel)

Aufgaben

• Ensure assessments address regulatory responsibilities
• Formulate and improve assessment procedures
• Independently manage certification projects
• Evaluate products against national and international standards
• Support the Commercial team with clinical assessment estimates
• Deliver projects within agreed timescales
• Review test data and reports
• Participate in assessments

Berufserfahrung

Ausbildung

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