Philips
Junior Management Regulatory Affairs Manager(m/w/x)
Full-timeOn-siteManagement
Böblingen
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PHPhilips
Regulatory Affairs Manager MS&S(m/w/x)
Böblingen
Full-timeOn-siteManagement
Nejo AI Summary
Leading regulatory SMEs for monitoring platforms and U.S. 510(k) submissions. 10+ years of medical device regulatory experience required. Health technology company, cross-functional alignment across product lifecycle.
Requirements
- 10+ years of Regulatory experience, including U.S. 510(k) submissions for vital signs monitoring platforms
- Experience in global medical device regulations and standards
- Led complex software-based regulatory submissions
- Project/program management experience
- Strong coaching and leadership skills
- Master’s or Diploma degree
- Field of study: Regulatory Affairs / 510(k) experience
- Fluent English
- 3–5 years of leadership or program management experience
- Many, but not all, of the experiences needed are encouraged
Tasks
- Lead and develop Regulatory SMEs for Monitoring Platforms and Solutions
- Oversee complex regulatory submissions, especially U.S. 510(k)
- Translate global regulatory requirements into product and software development
- Provide regulatory training and guidance to internal stakeholders
- Drive cross-functional alignment across the product lifecycle
- Shape regulatory strategy for Vital Signs Monitoring Platforms
- Ensure timely, high-quality regulatory approvals
- Collaborate with R&D, Quality, Marketing, and global Regulatory teams
- Manage complex platform and software submissions with multiple features and devices
- Align multiple global stakeholders
- Support Philips’ commitment to patient safety and innovation
Work Experience
- 3 - 5 years
Education
- Vocational certification
Languages
- English – Fluent
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
Regulatory Affairs Manager MS&S(m/w/x)
Böblingen
Full-timeOn-siteManagement
Nejo AI Summary
Leading regulatory SMEs for monitoring platforms and U.S. 510(k) submissions. 10+ years of medical device regulatory experience required. Health technology company, cross-functional alignment across product lifecycle.
Requirements
- 10+ years of Regulatory experience, including U.S. 510(k) submissions for vital signs monitoring platforms
- Experience in global medical device regulations and standards
- Led complex software-based regulatory submissions
- Project/program management experience
- Strong coaching and leadership skills
- Master’s or Diploma degree
- Field of study: Regulatory Affairs / 510(k) experience
- Fluent English
- 3–5 years of leadership or program management experience
- Many, but not all, of the experiences needed are encouraged
Tasks
- Lead and develop Regulatory SMEs for Monitoring Platforms and Solutions
- Oversee complex regulatory submissions, especially U.S. 510(k)
- Translate global regulatory requirements into product and software development
- Provide regulatory training and guidance to internal stakeholders
- Drive cross-functional alignment across the product lifecycle
- Shape regulatory strategy for Vital Signs Monitoring Platforms
- Ensure timely, high-quality regulatory approvals
- Collaborate with R&D, Quality, Marketing, and global Regulatory teams
- Manage complex platform and software submissions with multiple features and devices
- Align multiple global stakeholders
- Support Philips’ commitment to patient safety and innovation
Work Experience
- 3 - 5 years
Education
- Vocational certification
Languages
- English – Fluent
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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