W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtSenior
Berlin
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W.W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Berlin
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Compiling approval documents and controlling technical documentation for medical device conformity assessments at a healthcare component manufacturer. Advanced training as Manager Regulatory Affairs for Medical Devices required. Work in a manufacturing environment.
Anforderungen
- Completed studies in natural sciences, engineering, medical, or comparable field
- Advanced training 'Manager Regulatory Affairs for Medical Devices'
- English Level CEFR C1, German Level CEFR B2
- Quality-oriented, reliable, and dependable
- Self-motivated
- Team player
- Independent and self-reliant
- Excellent communication skills
- Well-structured and systematic way of working
Aufgaben
- Ensure medical devices meet regulatory requirements
- Compile approval-relevant documents, including free sales certificates
- Prepare documentation for evaluations by notified bodies and authorities
- Control technical documentation for conformity assessment procedures
- Assess compliance with essential requirements
- Prepare and release declarations of conformity
- Support development and updating of design control processes
- Participate in risk management, clinical evaluation, and usability file implementation
- Review and release approval-relevant documents in design control
- Evaluate change orders for regulatory relevance
- Process RA-related general inquiries
- Interpret standard requirements for clinical evaluation and safety
- Act as an interface between RA departments and external bodies
- Support audits in coordination with the Quality Management Representative
- Process safety-related complaints with the Medical Affairs team
- Monitor measures to maintain the Quality Management System
- Ensure compliance with quality, safety, and environmental regulations
- Implement instructions from quality and safety representatives
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens W.O.M. World of Medicine GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - Neo Temp GmbH
Fachreferent für Zulassungsangelegenheiten(m/w/x)
Vollzeitnur vor OrtSeniorBerlinab 60.000 / Jahr - W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - 6280 TIB Molbiol Syntheselabor GmbH
Regulatory Affairs Manager(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenBerlin
W.W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Berlin
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Compiling approval documents and controlling technical documentation for medical device conformity assessments at a healthcare component manufacturer. Advanced training as Manager Regulatory Affairs for Medical Devices required. Work in a manufacturing environment.
Anforderungen
- Completed studies in natural sciences, engineering, medical, or comparable field
- Advanced training 'Manager Regulatory Affairs for Medical Devices'
- English Level CEFR C1, German Level CEFR B2
- Quality-oriented, reliable, and dependable
- Self-motivated
- Team player
- Independent and self-reliant
- Excellent communication skills
- Well-structured and systematic way of working
Aufgaben
- Ensure medical devices meet regulatory requirements
- Compile approval-relevant documents, including free sales certificates
- Prepare documentation for evaluations by notified bodies and authorities
- Control technical documentation for conformity assessment procedures
- Assess compliance with essential requirements
- Prepare and release declarations of conformity
- Support development and updating of design control processes
- Participate in risk management, clinical evaluation, and usability file implementation
- Review and release approval-relevant documents in design control
- Evaluate change orders for regulatory relevance
- Process RA-related general inquiries
- Interpret standard requirements for clinical evaluation and safety
- Act as an interface between RA departments and external bodies
- Support audits in coordination with the Quality Management Representative
- Process safety-related complaints with the Medical Affairs team
- Monitor measures to maintain the Quality Management System
- Ensure compliance with quality, safety, and environmental regulations
- Implement instructions from quality and safety representatives
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens W.O.M. World of Medicine GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
W.O.M. World of Medicine GmbH
Branche
Healthcare
Beschreibung
The company creates engineered components and sub-systems for healthcare and advanced manufacturing, enhancing productivity and precision.
Noch nicht perfekt?
- W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - Neo Temp GmbH
Fachreferent für Zulassungsangelegenheiten(m/w/x)
Vollzeitnur vor OrtSeniorBerlinab 60.000 / Jahr - W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - 6280 TIB Molbiol Syntheselabor GmbH
Regulatory Affairs Manager(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenBerlin