W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeit
Senior
Keine Angabe
Berlin
W.
W.O.M. World of Medicine GmbH4 Tage
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeit
Senior
Keine Angabe
Berlin
Nejo KI-Zusammenfassung
In this role, you will navigate the regulatory landscape for medical devices, ensuring compliance and facilitating product approvals. Your day-to-day responsibilities will include compiling essential documentation, managing audits, and collaborating with various stakeholders to uphold quality standards.
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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
Keine Angabe
Berufserfahrung
2–5 Jahre
Deine 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
Sprachen
Englisch – verhandlungssicher
Deutsch – Grundkenntnisse
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