Director of Regulatory Affairs - Informatics

Job Title

Director of Regulatory Affairs - Informatics

Job Description

The Director of Regulatory Affairs Informatics leads regulatory strategy and execution for software-enabled solutions, both device and non-device across areas like PACS, radiology, cardiology, pathology, urology, and virtual care. The role ensures compliance with FDA, EU MDR, and global regulations, focusing on cloud, AI transformation, and third-party software integration.

Your Role

• Regulatory Leadership: Develop and implement global regulatory strategies for software-enabled medical devices (including SaMD, non-device health IT) across the product lifecycle.
• Compliance & Submissions: Oversee the preparation and submission of regulatory filings (e.g., FDA pre-submissions, IDE, 510(k), EU MDR Technical Files/Design Dossiers) for US, EU, and other markets. Support in post market activities to ensure devices remain compliant.
• Cross-Functional Collaboration: Partner with R&D, Quality, Clinical, and Product teams to ensure regulatory requirements are integrated into product development, especially for cloud-based and AI-driven solutions.
• Third-Party Software Management: Evaluate and manage regulatory implications of integrating third-party software and cloud services into medical device platforms.
• Team Development: Hire, mentor, and develop a high-performing global regulatory affairs team, fostering a culture of continuous learning and operational excellence.
• Regulatory Intelligence: Monitor and interpret evolving global regulations (FDA, EU MDR, MDD, MedDev, MDCG, QMS, cybersecurity, labeling, and safety risk management standards) and communicate their impact to stakeholders.
• Process Improvement: Drive efficiencies in regulatory operations, leveraging digital tools and best practices to streamline submissions and compliance activities.
• Stakeholder Engagement: Serve as the primary liaison with regulatory authorities (FDA, Notified Bodies, etc.), internal enterprise stakeholders and represent the organization in internal and external audits, inspections.
  
  

You're The Right Fit If

• Master’s degree (or equivalent) in Informatics, Engineering, Life Sciences, or a related field.
• 10+ years of regulatory affairs experience in the medical device industry, with significant exposure to software-enabled devices, and digital health.
• At least 5 years of functional management and strategic leadership, including building and leading regulatory teams.
• Demonstrated expertise in FDA and EU MDR submissions, including hands-on experience with PACS, radiology devices, and cardiology device software.
• Deep understanding of cloud computing, AI/ML applications in healthcare, and associated regulatory challenges.
• Proven track record of working with third-party software vendors and managing regulatory compliance for integrated solutions.
• Strong knowledge of QMS standards, software development lifecycle, cybersecurity, and labeling requirements.
  
  

Advantages

• Experience with global regulatory submissions beyond the US and EU (e.g., APAC, LATAM).
• Experience with digital health regulations, interoperability standards, and data privacy requirements.
• Excellent communication, negotiation, and stakeholder management skills.
• Software and AI related process improvement at the enterprise level.
• this position isn't open for relocation.
  
  

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.

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.