W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeit
Senior
Keine Angabe
Berlin
W.
W.O.M. World of Medicine GmbH1 Monat
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeit
Senior
Keine Angabe
Berlin
Nejo KI-Zusammenfassung
In this role, you will ensure that medical devices comply with regulatory standards while managing documentation and approvals. Your day-to-day responsibilities will involve collaborating with cross-functional teams, supporting audits, and addressing safety-related incidents.
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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
Bachelor-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine 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
Sprachen
Englisch – verhandlungssicher
Deutsch – verhandlungssicher
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