W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSenior
Berlin
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W.W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Berlin
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Ensuring regulatory compliance for engineered medical devices in healthcare and advanced manufacturing, coordinating cross-functional teams. Manager Regulatory Affairs for Medical Devices training and long-term functional experience required. Disability accommodation.
Anforderungen
- Long-term functional professional experience
- Studies in natural sciences, engineering, or medicine
- Manager Regulatory Affairs for Medical Devices training
- English Level CEFR C1
- German Level CEFR B2
- Quality-oriented, reliable, and dependable nature
- High level of self-motivation
- Teamwork skills
- Independence and self-reliance
- Excellent communication skills
- Well-structured and systematic working style
- Willingness to travel up to 10%
Aufgaben
- Ensure medical devices meet all regulatory requirements
- Perform timely regulatory submissions for market placement
- Anticipate and plan necessary regulatory tasks
- Coordinate relevant cross-functional teams
- Compile approval documents and legalizations
- Prepare documentation for notified bodies and authorities
- Control technical documentation for conformity assessments
- Prepare and release declarations of conformity
- Support development of design control processes
- Implement risk management and clinical evaluations
- Review and release design validation protocols
- Evaluate change orders for regulatory relevance
- Process general regulatory affairs inquiries
- Interpret standard requirements for electrical safety and cybersecurity
- Act as interface between customers and authorities
- Support audits in cooperation with the QMR
- Process safety-related complaints with Medical Affairs
- Monitor measures to maintain the quality management system
- Comply with occupational safety and environmental regulations
Berufserfahrung
- 5 - 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Benefits
Sonstige Vorteile
- Disability accommodation
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.
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W.W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Berlin
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Ensuring regulatory compliance for engineered medical devices in healthcare and advanced manufacturing, coordinating cross-functional teams. Manager Regulatory Affairs for Medical Devices training and long-term functional experience required. Disability accommodation.
Anforderungen
- Long-term functional professional experience
- Studies in natural sciences, engineering, or medicine
- Manager Regulatory Affairs for Medical Devices training
- English Level CEFR C1
- German Level CEFR B2
- Quality-oriented, reliable, and dependable nature
- High level of self-motivation
- Teamwork skills
- Independence and self-reliance
- Excellent communication skills
- Well-structured and systematic working style
- Willingness to travel up to 10%
Aufgaben
- Ensure medical devices meet all regulatory requirements
- Perform timely regulatory submissions for market placement
- Anticipate and plan necessary regulatory tasks
- Coordinate relevant cross-functional teams
- Compile approval documents and legalizations
- Prepare documentation for notified bodies and authorities
- Control technical documentation for conformity assessments
- Prepare and release declarations of conformity
- Support development of design control processes
- Implement risk management and clinical evaluations
- Review and release design validation protocols
- Evaluate change orders for regulatory relevance
- Process general regulatory affairs inquiries
- Interpret standard requirements for electrical safety and cybersecurity
- Act as interface between customers and authorities
- Support audits in cooperation with the QMR
- Process safety-related complaints with Medical Affairs
- Monitor measures to maintain the quality management system
- Comply with occupational safety and environmental regulations
Berufserfahrung
- 5 - 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Benefits
Sonstige Vorteile
- Disability accommodation
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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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 Medical Devices(m/w/x)
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Vollzeitnur vor OrtBerufserfahrenBerlin