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Regulatory Affairs Manager MS&S(m/w/x)
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
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Regulatory Affairs Manager MS&S(m/w/x)
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
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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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