Dedalus HealthCare
Product Management Teamlead ORBIS Medical Controlling(m/w/x)
Full-timeRemoteSenior
Bonn
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DEDedalus HealthCare
Pre Market Quality and Regulatory Specialist(m/w/x)
Bonn
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Verifying design history files and coordinating CE submissions for pre-market medical technology solutions. Subject matter expertise in regulatory affairs with 3+ years in a regulated industry required. Flexible working hours, home office option.
Requirements
- University Degree in Engineering, Computer Science, or Science or equivalent
- Minimum 3 years of experience in a regulated industry
- Ability to work independently towards project deadlines
- Strong attention to detail
- Subject matter expert in regulatory affairs
- In-depth knowledge of health care quality standards and requirements
- Awareness of Medical Device product safety and security standards
- Expert PC operation skills
- Knowledge of Microsoft Office applications (Intermediate to Advanced preferred)
- Mandatory language skills: German, English at least C1 or better
Tasks
- Ensure process adherence for pre-market procedures
- Verify completeness of design history files and regulatory submissions
- Ensure regulatory and process conformance in development and maintenance projects
- Create and maintain key regulatory deliverables for projects
- Coordinate regulatory and CE submissions with regional QARA organizations
- Moderate the medical device risk analysis process for the development team
- Facilitate regulatory compliance in design control processes
- Conduct internal audits and defend pre-market activities during external inspections
- Act as a QARA ambassador on product teams
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ISO 13485
- ISO 14971
- IEC 62304
- IEC 62366
- Medical Device Directive
- Medical Device Regulation MDR
- IVDR
- ISO 27001
- GDPR
- Microsoft Office
Benefits
Flexible Working
- Flexible working hours
- Home office
Job Security
- Permanent employment contract
Startup Environment
- Innovative workplace
Career Advancement
- Targeted advancement through training
Modern Equipment
- Company cell phone for private use
Parking & Commuter Benefits
- Free parking spaces
Snacks & Drinks
- Free drinks
- Weekly fruit basket
Retirement Plans
- Company pension plan
Other Benefits
- Group accident insurance
Healthcare & Fitness
- Foreign health insurance for business trips
Team Events
- Regular team activities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Dedalus HealthCare and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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DEDedalus HealthCare
Pre Market Quality and Regulatory Specialist(m/w/x)
Bonn
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Verifying design history files and coordinating CE submissions for pre-market medical technology solutions. Subject matter expertise in regulatory affairs with 3+ years in a regulated industry required. Flexible working hours, home office option.
Requirements
- University Degree in Engineering, Computer Science, or Science or equivalent
- Minimum 3 years of experience in a regulated industry
- Ability to work independently towards project deadlines
- Strong attention to detail
- Subject matter expert in regulatory affairs
- In-depth knowledge of health care quality standards and requirements
- Awareness of Medical Device product safety and security standards
- Expert PC operation skills
- Knowledge of Microsoft Office applications (Intermediate to Advanced preferred)
- Mandatory language skills: German, English at least C1 or better
Tasks
- Ensure process adherence for pre-market procedures
- Verify completeness of design history files and regulatory submissions
- Ensure regulatory and process conformance in development and maintenance projects
- Create and maintain key regulatory deliverables for projects
- Coordinate regulatory and CE submissions with regional QARA organizations
- Moderate the medical device risk analysis process for the development team
- Facilitate regulatory compliance in design control processes
- Conduct internal audits and defend pre-market activities during external inspections
- Act as a QARA ambassador on product teams
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ISO 13485
- ISO 14971
- IEC 62304
- IEC 62366
- Medical Device Directive
- Medical Device Regulation MDR
- IVDR
- ISO 27001
- GDPR
- Microsoft Office
Benefits
Flexible Working
- Flexible working hours
- Home office
Job Security
- Permanent employment contract
Startup Environment
- Innovative workplace
Career Advancement
- Targeted advancement through training
Modern Equipment
- Company cell phone for private use
Parking & Commuter Benefits
- Free parking spaces
Snacks & Drinks
- Free drinks
- Weekly fruit basket
Retirement Plans
- Company pension plan
Other Benefits
- Group accident insurance
Healthcare & Fitness
- Foreign health insurance for business trips
Team Events
- Regular team activities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Dedalus HealthCare and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Dedalus HealthCare
Industry
Healthcare
Description
Das Unternehmen verbessert die Gesundheitsversorgung durch innovative Lösungen und Dienstleistungen.
Not a perfect match?
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