W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteSenior
Berlin
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W.W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
Compiling approval documents and controlling technical documentation for medical device conformity assessments at a healthcare component manufacturer. Advanced training as Manager Regulatory Affairs for Medical Devices required. Work in a manufacturing environment.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
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
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
Compiling approval documents and controlling technical documentation for medical device conformity assessments at a healthcare component manufacturer. Advanced training as Manager Regulatory Affairs for Medical Devices required. Work in a manufacturing environment.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
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?
- W.O.M. World of Medicine GmbH
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