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CSCSA Group Bayern GmbH

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

Plattling
Full-timeWith Home OfficeSenior

Clinical assessments for medical device certification at a product testing and certification body, including procedure development and assessor training. 5+ years clinical experience and profound MD/IVD regulatory knowledge required. Work from home, flexible hours, bike leasing.

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

  • 5 years

Education

  • Bachelor's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Benefits

Flexible Working

  • Opportunity to work from home
  • Flexible working hours

Healthcare & Fitness

  • Fitness and health program

Company Bike

  • Lease a bike

Retirement Plans

  • Company pension plan

Other Benefits

  • Other corporate benefits

Learning & Development

  • Opportunities for constant training
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSA Group Bayern GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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