Philips
Regulatory Affairs Manager MS&S(m/w/x)
Full-timeOn-siteManagement
Böblingen
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PHPhilips
Junior Management Regulatory Affairs Manager(m/w/x)
Böblingen
Full-timeOn-siteManagement
Nejo AI Summary
Managing regulatory affairs for digital health platforms and cloud-based systems. Project management experience required. Training HPM employees on global regulatory standards.
Requirements
- Bachelor's or Master's degree in Regulatory, Labeling, IT/Database Management, or equivalent
- Expertise in interpreting and implementing global medical device regulations
- Experience in process improvement and implementation
- Project management experience required
- Strong knowledge of Quality Management Systems (QMS)
- Coaching and mentoring skills
- Cross-functional influence and advisory experience highly desirable
- Knowledge across Regulatory, IT, Labeling, and Database systems
Tasks
- Manage regulatory affairs for digital platforms and operations
- Lead and train HPM employees on global regulatory standards
- Interpret and implement regulatory requirements for digital labeling
- Optimize country-specific release requirements for cloud-based platforms
- Establish and maintain regulatory processes and procedures
- Support cross-functional teams in digital platform compliance
- Centralize administrative tasks for regulatory operations
- Manage registration prioritization dashboards
- Oversee RIMS/Rimsys and EUDAMED/GUDID database management
- Utilize Power BI, ReedTech, and KAIROS for regulatory tasks
- Partner with R&D, Quality, Regulatory, Marketing, and global teams
- Ensure global compliance for digital platforms and operations
Work Experience
- approx. 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- english – Business Fluent
Tools & Technologies
- IT tools supporting labeling
- digital platforms
- device master records
- device history records
- license management systems
- eIFU
- eLabels
- UDI
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Philips 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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PHPhilips
Junior Management Regulatory Affairs Manager(m/w/x)
Böblingen
Full-timeOn-siteManagement
Nejo AI Summary
Managing regulatory affairs for digital health platforms and cloud-based systems. Project management experience required. Training HPM employees on global regulatory standards.
Requirements
- Bachelor's or Master's degree in Regulatory, Labeling, IT/Database Management, or equivalent
- Expertise in interpreting and implementing global medical device regulations
- Experience in process improvement and implementation
- Project management experience required
- Strong knowledge of Quality Management Systems (QMS)
- Coaching and mentoring skills
- Cross-functional influence and advisory experience highly desirable
- Knowledge across Regulatory, IT, Labeling, and Database systems
Tasks
- Manage regulatory affairs for digital platforms and operations
- Lead and train HPM employees on global regulatory standards
- Interpret and implement regulatory requirements for digital labeling
- Optimize country-specific release requirements for cloud-based platforms
- Establish and maintain regulatory processes and procedures
- Support cross-functional teams in digital platform compliance
- Centralize administrative tasks for regulatory operations
- Manage registration prioritization dashboards
- Oversee RIMS/Rimsys and EUDAMED/GUDID database management
- Utilize Power BI, ReedTech, and KAIROS for regulatory tasks
- Partner with R&D, Quality, Regulatory, Marketing, and global teams
- Ensure global compliance for digital platforms and operations
Work Experience
- approx. 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- english – Business Fluent
Tools & Technologies
- IT tools supporting labeling
- digital platforms
- device master records
- device history records
- license management systems
- eIFU
- eLabels
- UDI
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Philips 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
Philips
Industry
Healthcare
Description
Das Unternehmen trägt durch innovative Lösungen zur Verbesserung der Lebensqualität von 3 Milliarden Menschen bei.
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