Aktuelle Jobs im Zusammenhang mit Clinical Reviewer MDR/IVDR Specialist - Plattling, Bayern - CSA Group
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Clinical Reviewer MDR/IVDR Specialist
vor 4 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR Specialist
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitRole 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...
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Clinical Reviewer MDR/IVDR Specialist
vor 4 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR Specialist
vor 4 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR Specialist
vor 2 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitRole 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...
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Clinical Reviewer MDR/IVDR Specialist
vor 2 Monaten
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR Specialist
vor 2 Monaten
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR Specialist
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR Specialist
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR Specialist
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR Expert
vor 3 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Clinical Reviewer MDR/IVDR Position
vor 2 Wochen
Plattling, Bayern, Deutschland CSA Group VollzeitKey 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...
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Senior Clinical Compliance Specialist
Vor 2 Tagen
Plattling, Bayern, Deutschland CSA Group VollzeitCompany Overview:CSA Group, a leading global provider of testing, inspection, and certification services, has been making the world a better, safer, more sustainable place for nearly a century.Headquartered in Canada, with a global footprint of over 30 labs and offices across Europe, Asia, and North America, CSA Group tests, inspects, and certifies a wide...
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Quality Management Specialist
vor 1 Monat
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Quality Management Specialist
vor 1 Monat
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Device Certification Specialist
Vor 6 Tagen
Plattling, Bayern, Deutschland CSA Group VollzeitAbout 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...
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Quality Management Specialist
vor 2 Monaten
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Quality Management Specialist
vor 2 Monaten
Plattling, Bayern, Deutschland CSA Group VollzeitJob 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...
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Quality Management Specialist
vor 2 Monaten
Plattling, Bayern, Deutschland CSA Group VollzeitAbout 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...
Clinical Reviewer MDR/IVDR Specialist
vor 2 Monaten
{"h1": "Clinical Reviewer MDR/IVDR Opportunity at CSA Group", "p": "At CSA Group, we are committed to making the world a better, safer, and more sustainable place. As a Clinical Reviewer MDR/IVDR, you will play a crucial role in supporting our Healthcare Regulatory Services Team in Germany and throughout Europe.
Your key responsibilities will include ensuring that assessments conducted have properly examined and addressed the regulatory responsibilities of the manufacturer with respect to product clinical performance. You will also be responsible for developing and delivering up-to-date training to clinical assessors, as well as running periodic calibration events for the clinical team.
To be successful in this role, you will need to have a university degree in medical or scientific university or polytechnic studies, or comparable professional knowledge. You will also require 5+ years of relevant clinical experience, as well as profound knowledge of the relevant regulations, directives, and guidelines for certification of MD/IVD devices.
We offer a dynamic and professional work environment, with opportunities for constant training and learning. You will also have access to a range of benefits, including a company pension plan, flexible working hours, and the opportunity to work from home.
If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
**Key Responsibilities:**
* 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
* Run periodic calibration events for the clinical team
* 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 product
* Represent CSA by actively participating in congresses as speaker in regards of 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
* Strong interpersonal skills
* Self-starter
* Good decision-making skills and organizational skills
* Excellent communication skills (verbal and written)
* Strong conflict resolution skills
* Good command in German and English language skill written and oral
**What We Offer:**
* Dynamic and professional work environment
* Opportunities for constant training and learning
* Company pension plan
* Flexible working hours
* Opportunity to work from home
* 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
* Other Corporate Benefits
**How to Apply:**
If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please submit your application, including your resume and a cover letter, to [insert contact information].
We look forward to hearing from you
