Clinical Reviewer MDR/IVDR Specialist
Vor 3 Tagen
{"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.
In return, you will enjoy a flat hierarchy in a professional and intercultural corporate environment, with opportunities to work from home and flexible working hours. You will also have access to attractive tasks, exciting projects, and the opportunity to contribute your own ideas.
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:**
* Flat hierarchy in a professional and intercultural corporate environment
* Opportunities 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
**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"}
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Clinical Reviewer MDR/IVDR Specialist
vor 2 Wochen
Plattling, Bayern, Deutschland CSA Group Vollzeit{"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...
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Clinical Reviewer MDR/IVDR Specialist
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Plattling, Bayern, Deutschland CSA Group Vollzeit{"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...
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Plattling, Bayern, Deutschland CSA Group Vollzeit{"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...
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Plattling, Bayern, Deutschland CSA Group Vollzeit{"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...
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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.Ensure that assessments conducted have...
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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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