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Clinical Reviewer MDR/IVDR(m/w/x)
Clinical assessments for medical device certification at a product testing and certification body, including procedure development and assessor training. 5+ years clinical experience and profound MD/IVD regulatory knowledge required. Work from home, flexible hours, bike leasing.
Requirements
- University degree in medical or scientific studies or comparable professional knowledge
- 5+ years of relevant clinical experience
- Profound knowledge of regulations for certification of MD/IVD devices
- Multiple years of experience in evaluation and decision making for medical devices
- Strong interpersonal skills, self-starter, good decision-making and organizational skills
- Ability to manage multiple clinical evaluations and changing schedules
- Excellent communication skills (verbal and written)
- Strong conflict resolution skills
- Good command in German and English; any other European language is a benefit
Tasks
- Support the MD/IVD assessment team in clinical assessments
- Ensure assessments address regulatory responsibilities for clinical performance
- Formulate and improve clinical assessment procedures and protocols
- Develop and deliver training for clinical assessors
- Conduct periodic calibration events for the clinical team
- Assist the Head of Medical Regulatory Services in demonstrating effective assessment procedures
- Oversee and review clinical data assessments for compliance with regulations
- Support the Commercial team in estimating efforts for clinical assessments
- Represent CSA at congresses as a speaker on technical and clinical subjects
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Flexible Working
- Opportunity to work from home
- Flexible working hours
Healthcare & Fitness
- Fitness and health program
Company Bike
- Lease a bike
Retirement Plans
- Company pension plan
Other Benefits
- Other corporate benefits
Learning & Development
- Opportunities for constant training
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Clinical Reviewer MDR/IVDR(m/w/x)
Clinical assessments for medical device certification at a product testing and certification body, including procedure development and assessor training. 5+ years clinical experience and profound MD/IVD regulatory knowledge required. Work from home, flexible hours, bike leasing.
Requirements
- University degree in medical or scientific studies or comparable professional knowledge
- 5+ years of relevant clinical experience
- Profound knowledge of regulations for certification of MD/IVD devices
- Multiple years of experience in evaluation and decision making for medical devices
- Strong interpersonal skills, self-starter, good decision-making and organizational skills
- Ability to manage multiple clinical evaluations and changing schedules
- Excellent communication skills (verbal and written)
- Strong conflict resolution skills
- Good command in German and English; any other European language is a benefit
Tasks
- Support the MD/IVD assessment team in clinical assessments
- Ensure assessments address regulatory responsibilities for clinical performance
- Formulate and improve clinical assessment procedures and protocols
- Develop and deliver training for clinical assessors
- Conduct periodic calibration events for the clinical team
- Assist the Head of Medical Regulatory Services in demonstrating effective assessment procedures
- Oversee and review clinical data assessments for compliance with regulations
- Support the Commercial team in estimating efforts for clinical assessments
- Represent CSA at congresses as a speaker on technical and clinical subjects
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Flexible Working
- Opportunity to work from home
- Flexible working hours
Healthcare & Fitness
- Fitness and health program
Company Bike
- Lease a bike
Retirement Plans
- Company pension plan
Other Benefits
- Other corporate benefits
Learning & Development
- Opportunities for constant training
About the Company
CSA Group Bayern GmbH
Industry
Healthcare
Description
The company tests, inspects, and certifies a wide range of products to meet safety, performance, and environmental standards.
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