regulatory information management systems (rimsys)
regulatory documentation
regulatory data management
regulatory compliance
regulatory strategy development
sap
product lifecycle management
regulatory risk assessment
regulatory gap assessment
regulatory reporting
power bi
power automate
stakeholder management
technical writing
microsoft office 365
ai/ml-based medical devices
cybersecurity regulations for medical devices
cloud regulations for medical devices
quality management systems
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Stay current with evolving regulations related to SaMD, cybersecurity, AI/ML, and cloud-based medical software
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Data Analytics & Reporting
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Develop and maintain dashboards and reports using tools like Power BI and Power Automate
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Provide insights on regulatory metrics, submission timelines, and compliance status
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Documentation & Knowledge Management
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Develop, review, and maintain high-quality regulatory documentation
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Collaborate with SMEs to gather technical content for submissions
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Establish standardized templates and documentation frameworks
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Required Qualifications
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Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related field
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10+ years of experience in Regulatory Affairs within the medical device industry
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Strong experience with Software as a Medical Device (SaMD) regulatory submissions
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Proven expertise in global regulatory frameworks (FDA, EU MDR, Health Canada, etc.)
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In-depth knowledge of IEC 62304, IEC 62366, and relevant medical device standards
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Preferred Qualifications
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RAPS Regulatory Affairs Certification (RAC)
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Experience with AI/ML-based medical devices and associated regulatory pathways
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Knowledge of cybersecurity and cloud regulations for medical devices
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Key Skills & Competencies
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Regulatory strategy and submission expertise
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Strong analytical and data management skills
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Advanced proficiency in Microsoft Office 365 tools (Excel, Power BI, Power Automate)
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Excellent documentation and technical writing skills
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Stakeholder management and cross-functional collaboration
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Attention to detail with a “first-time-right” mindset
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Work Environment & Impact
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Works under general direction with a high degree of independence
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Influences regulatory outcomes for global product launches
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Collaborates across global teams and regulatory bodies
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How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
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