Solventum
Supplier Quality Auditor(m/w/x)
Full-timeWith HomeofficeExperienced
Düsseldorf
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SOSolventum
Regulatory Affairs Administrator(m/w/x)
Düsseldorf
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Rebranding coordination for medical device artwork and technical documentation across EMEA manufacturing plants. Proficiency in medical device regulatory processes and quality management systems required. 30 days vacation, hybrid work model.
Requirements
- Bachelor’s Degree
- Fluent written and verbal English skills
- Understanding of medical device regulatory processes
- Knowledge in corporate quality management systems
- Knowledge in technical documentation for medical devices
- Communication, escalation, and follow-up skills
- Project coordination and problem-solving skills
- Legal authorization to work without sponsorship
Tasks
- Manage over 30 rebranding CMPs for EMEA MedSurg Business
- Coordinate rebranding with Solventum plants and vendors
- Improve processes to increase speed while maintaining compliance
- Support the creation of artwork redlines
- Approve incoming rebranded artworks
- Prepare and update technical documentation for medical devices
- Ensure compliance with EU MDR and ISO 13485 standards
- Manage documentation for Class I, IIa, IIb, and III devices
- Support SOS Regulatory Affairs via the Reg Desk
- Set up tracking systems for EU and DCTs
Work Experience
approx. 1 - 4 years
Education
Bachelor's degree
Languages
English – Business Fluent
Tools & Technologies
EU MDRISO 13485
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Solventum 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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SOSolventum
Regulatory Affairs Administrator(m/w/x)
Düsseldorf
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Rebranding coordination for medical device artwork and technical documentation across EMEA manufacturing plants. Proficiency in medical device regulatory processes and quality management systems required. 30 days vacation, hybrid work model.
Requirements
- Bachelor’s Degree
- Fluent written and verbal English skills
- Understanding of medical device regulatory processes
- Knowledge in corporate quality management systems
- Knowledge in technical documentation for medical devices
- Communication, escalation, and follow-up skills
- Project coordination and problem-solving skills
- Legal authorization to work without sponsorship
Tasks
- Manage over 30 rebranding CMPs for EMEA MedSurg Business
- Coordinate rebranding with Solventum plants and vendors
- Improve processes to increase speed while maintaining compliance
- Support the creation of artwork redlines
- Approve incoming rebranded artworks
- Prepare and update technical documentation for medical devices
- Ensure compliance with EU MDR and ISO 13485 standards
- Manage documentation for Class I, IIa, IIb, and III devices
- Support SOS Regulatory Affairs via the Reg Desk
- Set up tracking systems for EU and DCTs
Work Experience
approx. 1 - 4 years
Education
Bachelor's degree
Languages
English – Business Fluent
Tools & Technologies
EU MDRISO 13485
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Solventum 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
Solventum
Industry
Healthcare
Description
Das Unternehmen ermöglicht eine bessere, intelligentere und sicherere Gesundheitsversorgung und leistet Pionierarbeit an der Schnittstelle von Gesundheit, Material- und Datenwissenschaft.
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