W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Full-timeOn-siteSenior
Berlin
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W.W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 2 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of W.O.M. World of Medicine GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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W.W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 2 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of W.O.M. World of Medicine GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
W.O.M. World of Medicine GmbH
Industry
Healthcare
Description
The company creates engineered components and sub-systems for healthcare and advanced manufacturing, enhancing productivity and precision.
Not a perfect match?
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