MED CARE VISIONS® GmbH
Quality and Regulatory Affairs Manager(m/w/x)
Full-timeOn-siteSenior
Unterschleißheim
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IMImFusion GmbH
Quality & Regulatory Affairs Lead – Medical Device Software (SaMD/SiMD)(m/w/x)
München
Full-timeOn-siteSenior
Nejo AI Summary
Developing regulatory strategies for medical device software, guiding documentation for interventional planning software at medical imaging R&D consulting firm. Quality management, regulatory affairs, and external audit coordination experience required; ISO 13485, MDR, FDA knowledge essential. Bike leasing and Deutschlandticket provided.
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
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
Work Experience
- 2 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- MDR
- FDA
- QMS
- IEC 62304
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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IMImFusion GmbH
Quality & Regulatory Affairs Lead – Medical Device Software (SaMD/SiMD)(m/w/x)
München
Full-timeOn-siteSenior
Nejo AI Summary
Developing regulatory strategies for medical device software, guiding documentation for interventional planning software at medical imaging R&D consulting firm. Quality management, regulatory affairs, and external audit coordination experience required; ISO 13485, MDR, FDA knowledge essential. Bike leasing and Deutschlandticket provided.
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
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
Work Experience
- 2 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- MDR
- FDA
- QMS
- IEC 62304
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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