Vara
Quality Manager in Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeExperienced
Berlin
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ADAda Health GmbH
Quality, Regulatory & Risk Manager(m/w/x)
Berlin
Full-timeWith Home OfficeExperienced
AI/ML
Nejo AI Summary
Overseeing medical device lifecycle risk assessments and QMS compliance for healthcare tech products. Medical device risk management experience and MDR/ISO 13485 knowledge required. Flexible working hours.
Requirements
- Experience in QA, RA, and QMS
- Experience in medical device risk management
- Knowledge of MDR and ISO standards
- Knowledge of QMS and support tools
- Ability to mitigate regulatory risks
- Experience supporting audits and investigations
- Strong analytical and problem-solving skills
Tasks
- Maintain and improve the Quality Management System
- Ensure compliance with ISO 13485 and MDR
- Develop SOPs and technical documentation
- Provide technical writing and SME support
- Manage medical device lifecycle risk assessments
- Execute failure mode analyses and mitigation strategies
- Assess nonconformance records and audit findings
- Manage corrective and preventive actions
- Coordinate internal and external supplier audits
- Train stakeholders on quality and regulatory standards
- Support product verification and validation activities
- Oversee production controls and inspection activities
- Collaborate on cross-functional product change management
- Drive continuous improvement for patient safety
- Promote a culture of regulatory compliance
Work Experience
- 2 - 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Jira
- Github
- Regulation (EU) 2017/745 (MDR)
- EU AI Act
- MPDG
- ISO 13485
- ISO 14971
- IEC 62304
- IEC 82304
Benefits
Flexible Working
- Flexible working hours
Healthcare & Fitness
- Corporate health insurance (UK)
- Discounted ClassPass membership
- Urban Sports Club membership
Retirement Plans
- Pension scheme (UK)
Modern Equipment
- Home office setup support
Startup Environment
- Co-working space subscription
Generous Parental Leave
- Parental benefits
Childcare
- Nursery benefits (UK)
Mental Health Support
- Employee Assistance Programs
Company Bike
- Bike Leasing Scheme (Germany)
Learning & Development
- Online Academy
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ada Health GmbH 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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ADAda Health GmbH
Quality, Regulatory & Risk Manager(m/w/x)
Berlin
Full-timeWith Home OfficeExperienced
AI/ML
Nejo AI Summary
Overseeing medical device lifecycle risk assessments and QMS compliance for healthcare tech products. Medical device risk management experience and MDR/ISO 13485 knowledge required. Flexible working hours.
Requirements
- Experience in QA, RA, and QMS
- Experience in medical device risk management
- Knowledge of MDR and ISO standards
- Knowledge of QMS and support tools
- Ability to mitigate regulatory risks
- Experience supporting audits and investigations
- Strong analytical and problem-solving skills
Tasks
- Maintain and improve the Quality Management System
- Ensure compliance with ISO 13485 and MDR
- Develop SOPs and technical documentation
- Provide technical writing and SME support
- Manage medical device lifecycle risk assessments
- Execute failure mode analyses and mitigation strategies
- Assess nonconformance records and audit findings
- Manage corrective and preventive actions
- Coordinate internal and external supplier audits
- Train stakeholders on quality and regulatory standards
- Support product verification and validation activities
- Oversee production controls and inspection activities
- Collaborate on cross-functional product change management
- Drive continuous improvement for patient safety
- Promote a culture of regulatory compliance
Work Experience
- 2 - 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Jira
- Github
- Regulation (EU) 2017/745 (MDR)
- EU AI Act
- MPDG
- ISO 13485
- ISO 14971
- IEC 62304
- IEC 82304
Benefits
Flexible Working
- Flexible working hours
Healthcare & Fitness
- Corporate health insurance (UK)
- Discounted ClassPass membership
- Urban Sports Club membership
Retirement Plans
- Pension scheme (UK)
Modern Equipment
- Home office setup support
Startup Environment
- Co-working space subscription
Generous Parental Leave
- Parental benefits
Childcare
- Nursery benefits (UK)
Mental Health Support
- Employee Assistance Programs
Company Bike
- Bike Leasing Scheme (Germany)
Learning & Development
- Online Academy
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ada Health GmbH 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
Ada Health GmbH
Industry
Healthcare
Description
The company helps people get answers faster in healthcare, identifying those at risk and guiding them to the right care.
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