LivaNova Deutschland GmbH
Senior Verification Engineer(m/w/x)
Full-timeOn-siteSenior
München
New Job?Nejo!
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IM
ImFusion GmbHQuality & Regulatory Affairs Lead – Medical Device Software (SaMD/SiMD)(m/w/x)
München
Full-timeOn-siteSenior
Description
In this hands-on leadership role, you will shape regulatory strategy for medical device software while building a dedicated team and ensuring products meet the highest global standards.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Experience in quality management and regulatory affairs
- •Knowledge of ISO 13485, MDR, and FDA
- •Experience coordinating audits with external auditors
- •Hands-on execution and pragmatic leadership skills
- •Ownership of complex end-to-end projects
- •Strong communication and professional confidence
- •Motivation to build quality organizations
Education
Bachelor's degree
OR
Master's degree
Work Experience
2 - 5 years
Tasks
- •Define regulatory strategies for SaMD and SiMD projects
- •Ensure compliance with MDR and FDA expectations
- •Guide documentation for interventional planning software
- •Maintain and improve the ISO 13485 QMS
- •Implement quality policies and monitor KPIs
- •Coordinate internal and external audits
- •Assess the impact of regulatory changes
- •Promote a company-wide culture of compliance
- •Support business development and project scoping
- •Hire and mentor the Quality Management team
- •Execute hands-on documentation and compliance work
Tools & Technologies
ISO 13485MDRFDAQMSIEC 62304
Languages
English – Business Fluent
Benefits
Company Bike
- •Bike leasing
Healthcare & Fitness
- •Sports programs
Public Transport Subsidies
- •Deutschlandticket
Team Events
- •Team events
- •Summer party
- •Oktoberfest
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ImFusion 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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IM
ImFusion GmbHQuality & Regulatory Affairs Lead – Medical Device Software (SaMD/SiMD)(m/w/x)
München
Full-timeOn-siteSenior
New Job?Nejo!
The AI Job Search Engine
Description
In this hands-on leadership role, you will shape regulatory strategy for medical device software while building a dedicated team and ensuring products meet the highest global standards.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Experience in quality management and regulatory affairs
- •Knowledge of ISO 13485, MDR, and FDA
- •Experience coordinating audits with external auditors
- •Hands-on execution and pragmatic leadership skills
- •Ownership of complex end-to-end projects
- •Strong communication and professional confidence
- •Motivation to build quality organizations
Education
Bachelor's degree
OR
Master's degree
Work Experience
2 - 5 years
Tasks
- •Define regulatory strategies for SaMD and SiMD projects
- •Ensure compliance with MDR and FDA expectations
- •Guide documentation for interventional planning software
- •Maintain and improve the ISO 13485 QMS
- •Implement quality policies and monitor KPIs
- •Coordinate internal and external audits
- •Assess the impact of regulatory changes
- •Promote a company-wide culture of compliance
- •Support business development and project scoping
- •Hire and mentor the Quality Management team
- •Execute hands-on documentation and compliance work
Tools & Technologies
ISO 13485MDRFDAQMSIEC 62304
Languages
English – Business Fluent
Benefits
Company Bike
- •Bike leasing
Healthcare & Fitness
- •Sports programs
Public Transport Subsidies
- •Deutschlandticket
Team Events
- •Team events
- •Summer party
- •Oktoberfest
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ImFusion 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
ImFusion GmbH
Industry
Healthcare
Description
The company is a R&D consulting firm specializing in medical imaging technologies, AI, and robotics.
Not a perfect match?
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