Aktuelle Jobs im Zusammenhang mit Clinical Reviewer Mdr/ivdr - Plattling - CSA Group
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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...
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Clinical Reviewer MDR/IVDR Specialist
Vor 3 Tagen
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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Clinical Reviewer MDR/IVDR Specialist
Vor 3 Tagen
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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Clinical Reviewer MDR/IVDR Specialist
vor 1 Tag
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 maintain clinical assessment...
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Clinical Reviewer MDR/IVDR Specialist
vor 1 Tag
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 maintain clinical assessment...
-
Clinical Reviewer MDR/IVDR Specialist
Vor 3 Tagen
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...
-
Clinical Reviewer MDR/IVDR Specialist
Vor 3 Tagen
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...
-
Clinical Reviewer MDR/IVDR Specialist
vor 1 Tag
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...
-
Clinical Reviewer MDR/IVDR Specialist
vor 1 Tag
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...
-
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...
-
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
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Plattling, Deutschland CSA Group VollzeitEmployment Status: Regular Time Type: Full time BUILDING A WORLD CLASS TEAM STARTS WITH YOU At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards,...
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Clinical Reviewer Mdr/ivdr
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Plattling, Deutschland CSA Group VollzeitStatut d'emploi: Regular - Type d'heures: Full time Nous avons besoin de vous pour former une équipe de calibre mondial Les activités du Groupe CSA reposent sur l’atteinte d’un idéal : rendre le monde meilleur, plus sûr et plus durable.Cet ideal est au coeur de notre mission depuis 1919, année où nous avons élaboré notre première norme...
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Clinical Assessment Specialist MDR/IVDR
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Clinical Assessment Specialist MDR/IVDR
vor 1 Monat
Plattling, Bayern, Deutschland CSA Group VollzeitEmployment Status: Permanent Time Type: Full-time BUILDING A WORLD CLASS TEAM STARTS WITH YOU At CSA Group, we are driven by a vision to enhance safety, sustainability, and quality of life globally. For nearly a century, we have been at the forefront of developing standards that ensure products meet rigorous safety and performance criteria. With...
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Clinical Evaluation Specialist MDR/IVDR
vor 1 Monat
Plattling, Bayern, Deutschland CSA Group VollzeitEmployment Status: Permanent Time Type: Full-time BUILDING A WORLD CLASS TEAM STARTS WITH YOU At CSA Group, we are driven by a vision of creating a better, safer, and more sustainable world. This mission has been our guiding principle for nearly a century, evolving from the establishment of the first engineering standard for railway bridges in 1919 to...
-
Clinical Evaluation Specialist MDR/IVDR
vor 1 Monat
Plattling, Bayern, Deutschland CSA Group VollzeitEmployment Status: Permanent Time Type: Full-time BUILDING A WORLD CLASS TEAM STARTS WITH YOU At CSA Group, we envision a better, safer, and more sustainable world. This vision has guided our mission for nearly a century, from establishing the first engineering standard for railway bridges in 1919 to developing over 3,500 standards, codes, and related...
Clinical Reviewer Mdr/ivdr
vor 4 Monaten
Employment Status:
Regular
Time Type:
Full time
BUILDING A WORLD CLASS TEAM STARTS WITH YOU
At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes & related products today.
Headquartered in Canada, with a global footprint of more than 30 labs and offices across Europe, Asia and North America, CSA Group tests, inspects and certifies a wide range of products - from every day househould items to leading edge technology-to meet exacting requirements for safety, performance and environmental impact.
Our employees take pride in making a difference in people's lives through the work that we do. We're looking for people like you to help make it happen.
Job Summary:
- CSA Group Europe has an opportunity for a Clinical Reviewer MDR/IVDR (f/m/d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe.
The Clinical Reviewer 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.
- These are your duties:_- 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. In this responsibility the CR is expected to formulate, maintain and improve clinical assessment procedures and protocols in line with both CSA Group and external Authority expectations-
- 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 product on an as needed basis- What_
- _
- we_
- _
- expect_
- :_- 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 and2017/746), 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 skill 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- CSA Group is an Equal Opportunity Employer and is committed to diversity, equity, and inclusion. We prohibit discrimination and harassment of any kind based on any grounds stipulated by applicable laws. We are an organization where opportunities are based on skills and abilities, and differences are respected and valued. Please contact us at _
- if you require accommodation in the interview process._
