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
Lead Regulatory Affairs Specialist(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring regulatory compliance for engineered medical devices in healthcare and advanced manufacturing, coordinating cross-functional teams. Manager Regulatory Affairs for Medical Devices training and long-term functional experience required. Disability accommodation.
Requirements
- Long-term functional professional experience
- Studies in natural sciences, engineering, or medicine
- Manager Regulatory Affairs for Medical Devices training
- English Level CEFR C1
- German Level CEFR B2
- Quality-oriented, reliable, and dependable nature
- High level of self-motivation
- Teamwork skills
- Independence and self-reliance
- Excellent communication skills
- Well-structured and systematic working style
- Willingness to travel up to 10%
Tasks
- Ensure medical devices meet all regulatory requirements
- Perform timely regulatory submissions for market placement
- Anticipate and plan necessary regulatory tasks
- Coordinate relevant cross-functional teams
- Compile approval documents and legalizations
- Prepare documentation for notified bodies and authorities
- Control technical documentation for conformity assessments
- Prepare and release declarations of conformity
- Support development of design control processes
- Implement risk management and clinical evaluations
- Review and release design validation protocols
- Evaluate change orders for regulatory relevance
- Process general regulatory affairs inquiries
- Interpret standard requirements for electrical safety and cybersecurity
- Act as interface between customers and authorities
- Support audits in cooperation with the QMR
- Process safety-related complaints with Medical Affairs
- Monitor measures to maintain the quality management system
- Comply with occupational safety and environmental regulations
Work Experience
- 5 - 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Benefits
Other Benefits
- Disability accommodation
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(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring regulatory compliance for engineered medical devices in healthcare and advanced manufacturing, coordinating cross-functional teams. Manager Regulatory Affairs for Medical Devices training and long-term functional experience required. Disability accommodation.
Requirements
- Long-term functional professional experience
- Studies in natural sciences, engineering, or medicine
- Manager Regulatory Affairs for Medical Devices training
- English Level CEFR C1
- German Level CEFR B2
- Quality-oriented, reliable, and dependable nature
- High level of self-motivation
- Teamwork skills
- Independence and self-reliance
- Excellent communication skills
- Well-structured and systematic working style
- Willingness to travel up to 10%
Tasks
- Ensure medical devices meet all regulatory requirements
- Perform timely regulatory submissions for market placement
- Anticipate and plan necessary regulatory tasks
- Coordinate relevant cross-functional teams
- Compile approval documents and legalizations
- Prepare documentation for notified bodies and authorities
- Control technical documentation for conformity assessments
- Prepare and release declarations of conformity
- Support development of design control processes
- Implement risk management and clinical evaluations
- Review and release design validation protocols
- Evaluate change orders for regulatory relevance
- Process general regulatory affairs inquiries
- Interpret standard requirements for electrical safety and cybersecurity
- Act as interface between customers and authorities
- Support audits in cooperation with the QMR
- Process safety-related complaints with Medical Affairs
- Monitor measures to maintain the quality management system
- Comply with occupational safety and environmental regulations
Work Experience
- 5 - 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Benefits
Other Benefits
- Disability accommodation
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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