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
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Berlin
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Preparing registration documents and free sales certificates for engineered healthcare components at a specialized manufacturing firm. In-depth regulatory knowledge and complex problem analysis skills essential. Work with advanced manufacturing technologies for critical healthcare applications.
Anforderungen
- 2-5 years of relevant professional experience
- Ability to conduct extensive research, in-depth knowledge, and creativity
- Ability to analyze proposed solutions to complex problems
- General knowledge of the manufacturing process
- Quality-conscious, trustworthy, and reliable
- Willingness to travel to all locations and business contacts
- Team player
- Communicative skills
- Structured and systematic way of working
Aufgaben
- Compile registration documents for customers in third countries
- Prepare free sales certificates and legalizations
- Gather documentation for Notified Body tests under EU Medical Devices Directive
- Control and accept technical documentation for conformity assessment
- Assess compliance with Essential Requirements
- Prepare and release declarations of conformity
- Update design guidance procedures and related policies
- Contribute to risk management and clinical evaluation processes
- Review and approve regulatory documents for design governance
- Process change requests and assess their relevance to approvals
- Serve as a contact for inquiries regarding regulatory standards
- Interface with RA departments, Notified Body, and authorities
- Coordinate audits with customers, authorities, and suppliers
- Handle safety-related complaints with the QM team
- Participate in maintaining the Quality Management System
- Engage in the innovation process
- Ensure compliance with quality, safety, and environmental regulations
- Make decisions on complex problem solutions
- Consult and train less experienced personnel
- Perform technical and process-related leadership duties
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
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
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Vollzeitnur vor OrtSeniorBerlinab 60.000 / Jahr - W.O.M. World of Medicine GmbH
Senior Systems Engineer Medical Devices(m/w/x)
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Vollzeit/Teilzeitnur vor OrtBerufserfahrenBerlin
W.W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Berlin
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Preparing registration documents and free sales certificates for engineered healthcare components at a specialized manufacturing firm. In-depth regulatory knowledge and complex problem analysis skills essential. Work with advanced manufacturing technologies for critical healthcare applications.
Anforderungen
- 2-5 years of relevant professional experience
- Ability to conduct extensive research, in-depth knowledge, and creativity
- Ability to analyze proposed solutions to complex problems
- General knowledge of the manufacturing process
- Quality-conscious, trustworthy, and reliable
- Willingness to travel to all locations and business contacts
- Team player
- Communicative skills
- Structured and systematic way of working
Aufgaben
- Compile registration documents for customers in third countries
- Prepare free sales certificates and legalizations
- Gather documentation for Notified Body tests under EU Medical Devices Directive
- Control and accept technical documentation for conformity assessment
- Assess compliance with Essential Requirements
- Prepare and release declarations of conformity
- Update design guidance procedures and related policies
- Contribute to risk management and clinical evaluation processes
- Review and approve regulatory documents for design governance
- Process change requests and assess their relevance to approvals
- Serve as a contact for inquiries regarding regulatory standards
- Interface with RA departments, Notified Body, and authorities
- Coordinate audits with customers, authorities, and suppliers
- Handle safety-related complaints with the QM team
- Participate in maintaining the Quality Management System
- Engage in the innovation process
- Ensure compliance with quality, safety, and environmental regulations
- Make decisions on complex problem solutions
- Consult and train less experienced personnel
- Perform technical and process-related leadership duties
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
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 Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(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
Senior Systems Engineer Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - 6280 TIB Molbiol Syntheselabor GmbH
Regulatory Affairs Manager(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenBerlin