Clinical Reviewer MDR/IVDR Specialist

vor 3 Wochen

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.

The successful candidate will support the MD/IVD assessment team in delivering clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.

Key Responsibilities:

  • To ensure that assessments conducted have properly examined and addressed the regulatory responsibilities of the manufacturer with respect to product clinical performance, including alignment with state-of-the-art expectations and defended risk/benefit for the product.
  • Responsible for developing and delivering up-to-date training to clinical assessors as well as running 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 and that clinical assessment projects have been conducted and reviewed according to CSA Group procedures.
  • Provide oversight and review of clinical data assessments performed by other deployed clinical staff (internal and external) in relation to customer compliance with relevant National and International Regulations and Norms.
  • Support the Commercial team in the formulation and effort estimation for the clinical assessments of products on an as-needed basis.
  • Represent CSA Group by actively participating in congresses as a speaker in regards to technical/clinical subjects.

Requirements:

  • University degree in medical or scientific university or polytechnic studies; or comparable professional knowledge.
  • 5+ years of relevant clinical experience.
  • Profound knowledge of the relevant regulations, directives, and guidelines for certification of MD/IVD devices (Regulations (EU) 2017/745 and 2017/746), relevant MDCGs as well as the role of the Notified Body.
  • 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 with supervision.
  • Excellent communication skills (verbal and written).
  • Strong conflict resolution skills to be able to handle difficult situations.
  • Good command in German and English language skills (written and oral). Any other European language beside German and English will be a benefit.

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.

  • Clinical Reviewer MDR/IVDR Specialist

    vor 1 Monat

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job SummaryCSA Group Europe is seeking a highly skilled Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.Key ResponsibilitiesConduct clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.Develop and maintain clinical assessment...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 1 Monat

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job SummaryCSA Group Europe is seeking a highly skilled Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.Key ResponsibilitiesConduct clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.Develop and maintain clinical assessment...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 3 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job SummaryCSA Group Europe is seeking a highly skilled Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.Key ResponsibilitiesConduct clinical assessments of medical devices under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.Develop and maintain clinical...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 2 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Role Overview:Clinical Reviewer MDR/IVDR at CSA Group EuropeCSA Group Europe is seeking a highly skilled Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.The successful candidate will support the MD/IVD assessment team in the delivery of clinical assessments of products under the European Regulations...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 4 Wochen

    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...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 4 Wochen

    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...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 2 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Role OverviewClinical Reviewer MDR/IVDR Specialist will be part of our Healthcare Regulatory Services Team in Germany and throughout Europe.The successful candidate will support the MD/IVD assessment team in the delivery of clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.Ensure that...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 1 Monat

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job SummaryCSA Group Europe is seeking a highly skilled Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.Key ResponsibilitiesConduct clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.Develop and deliver up-to-date training to...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 1 Monat

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job SummaryCSA Group Europe is seeking a highly skilled Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.Key ResponsibilitiesConduct clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.Develop and deliver up-to-date training to...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 3 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job Summary:CSA Group Europe is seeking a Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.The successful candidate will support the MD/IVD assessment team in the delivery of clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.Key...

  • Clinical Reviewer MDR/IVDR Specialist

    vor 3 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job Opportunity:CSA Group Europe is seeking a highly skilled Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.The successful candidate will support the MD/IVD assessment team in delivering clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices...

  • Clinical Reviewer MDR/IVDR

    vor 2 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job Summary:CSA Group Europe is seeking a Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.The successful candidate will support the MD/IVD assessment team in the delivery of clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.Key...

  • Clinical Reviewer MDR/IVDR Expert

    vor 2 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job SummaryCSA Group Europe seeks a skilled Clinical Reviewer MDR/IVDR to join our Healthcare Regulatory Services Team in Germany and throughout Europe.The selected candidate will support the MD/IVD assessment team in delivering clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.Ensure...

  • Clinical Reviewer MDR/IVDR Position

    vor 2 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Key Responsibilities:As a Clinical Reviewer at CSA Group, you will support the Medical Device/In Vitro Diagnostic (MD/IVD) assessment team in delivering clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.You will be responsible for ensuring that assessments conducted have properly...

  • Quality Management Specialist

    vor 4 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job SummaryWe are seeking an experienced Quality Management Specialist to join our team at CSA Group.Key ResponsibilitiesDevelop, implement, and monitor quality management systems according to ISO/IEC 17065 and ISO/IEC 17025 standards.Organize and execute internal and external quality management system audits.Drive continuous improvement initiatives to...

  • Quality Management Specialist

    vor 4 Wochen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job SummaryWe are seeking an experienced Quality Management Specialist to join our team at CSA Group.Key ResponsibilitiesDevelop, implement, and monitor quality management systems according to ISO/IEC 17065 and ISO/IEC 17025 standards.Organize and execute internal and external quality management system audits.Drive continuous improvement initiatives to...

  • Device Certification Specialist

    Vor 2 Tagen

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    About CSA GroupCSA Group is a leading organization dedicated to making the world a better, safer, and more sustainable place. With a rich history spanning nearly a century, we have been at the forefront of developing standards and testing products to ensure they meet exacting requirements for safety, performance, and environmental impact.Job Summary:A...

  • Quality Management Specialist

    vor 2 Monaten

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job Summary:We are seeking an experienced Quality Management Specialist to join our team at CSA Group.As a key member of our organization, you will play a crucial role in ensuring that all our facilities consistently deliver top-quality services to both internal and external customers.Key Responsibilities:Develop, implement, and monitor the quality...

  • Quality Management Specialist

    vor 2 Monaten

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    Job Summary:We are seeking an experienced Quality Management Specialist to join our team at CSA Group.As a key member of our organization, you will play a crucial role in ensuring that all our facilities consistently deliver top-quality services to both internal and external customers.Key Responsibilities:Develop, implement, and monitor the quality...

  • Quality Management Specialist

    vor 2 Monaten

    Plattling, Bayern, Deutschland CSA Group Vollzeit

    About CSA Group CSA Group is a global organization dedicated to safety, sustainability, and social good. We develop standards, test products, and provide certification services to ensure that the world's goods meet rigorous quality and performance requirements. Job Summary We are seeking a highly motivated and experienced Quality Management Specialist to...