Clinical Reviewer MDR/IVDR Specialist

vor 1 Tag


Plattling, Bayern, Deutschland CSA Group Vollzeit
Job Summary

CSA Group Europe is seeking a highly skilled Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.

Key Responsibilities
  • Conduct clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.
  • Develop and maintain clinical assessment procedures and protocols in line with CSA Group and external Authority expectations.
  • Provide training and calibration events for the clinical team.
  • Support the Head of Medical Regulatory Services in demonstrating compliance with relevant authorities.
  • Review clinical data assessments performed by other staff.
  • Support the Commercial team in clinical assessment efforts.
  • Represent CSA Group at congresses and events.
Requirements
  • University degree in medical or scientific field.
  • 5+ years of relevant clinical experience.
  • Profound knowledge of relevant regulations and guidelines.
  • Strong interpersonal and decision-making skills.
  • Excellent communication and conflict resolution skills.
  • Good command of German and English language skills.
What We Offer
  • Flat hierarchies in a professional and intercultural corporate environment.
  • Opportunity to work from home and flexible working hours.
  • Attractive tasks and exciting projects.
  • Opportunities for constant training and learning.
  • Permanent employment.


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