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Regulatory Affairs Administrator(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- EU MDR
- ISO 13485
Noch nicht perfekt?
- SolventumVollzeitmit HomeofficeBerufserfahrenDüsseldorf
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Regulatory Affairs Administrator(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- EU MDR
- ISO 13485
Über das Unternehmen
Solventum
Branche
Healthcare
Beschreibung
Das Unternehmen ermöglicht eine bessere, intelligentere und sicherere Gesundheitsversorgung und leistet Pionierarbeit an der Schnittstelle von Gesundheit, Material- und Datenwissenschaft.
Noch nicht perfekt?
- Solventum
Supplier Quality Auditor(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenDüsseldorf - Solventum
EMEA Portfolio Manager - Negative Pressure Wound Therapy(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenDüsseldorf - Solventum
EMEA Portfolio Leader - Sterilization and Perioperative(m/w/x)
Vollzeitmit HomeofficeSeniorDüsseldorf - Renesas Electronics
Administrative Assistant(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenDüsseldorf - DEU Medtronic GmbH
Peripheral Vascular Health Marketing Specialist(m/w/x)
Vollzeitmit HomeofficeJuniorMeerbuschab 50.400 - 75.600 / Jahr