Clinical Reviewer MDR/IVDR Specialist

Vor 3 Tagen

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.
  • Ensure that assessments conducted have properly examined and addressed the regulatory responsibilities of the manufacturer with respect to product clinical performance.
  • Develop and deliver up-to-date training to clinical assessors and run periodic calibration events for the clinical team.
  • Support the Head of Medical Regulatory Services in demonstrating to the relevant authorities that appropriate clinical assessment procedures and protocols are in place and effective.
  • Provide oversight and review of clinical data assessments performed by other deployed clinical staff.
  • Support the Commercial team in the formulation and effort estimation for the clinical assessments of products.
  • Represent CSA Group by actively participating in congresses as a speaker on technical/clinical subjects.
Requirements
  • University degree in medical or scientific university or polytechnic studies.
  • 5+ years of relevant clinical experience.
  • Profound knowledge of the relevant regulations, directives, and guidelines for certification of MD/IVD devices.
  • Multiple years of experience in the field of evaluation and decision making for medical and/or IV devices under conformity assessment procedures.
  • Strong interpersonal skills, self-starter, good decision-making skills, and organizational skills.
  • Ability to manage multiple clinical evaluations and changing schedules and deadlines.
  • Excellent communication skills (verbal and written).
  • Strong conflict resolution skills to handle difficult situations.
  • Good command of German and English language skills (written and oral).
What We Offer
  • Flat hierarchies in a professional and intercultural corporate environment.
  • Opportunity to work from home and flexible working hours.
  • Attractive tasks, exciting projects, and the opportunity to contribute your own ideas.
  • Fitness and health program for a relaxed balance to the daily work routine.
  • Lease a Bike.
  • Company pension plan.
  • Other Corporate Benefits.
  • Opportunities for constant training/learning.
  • Permanent employment.

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