Director of Regulatory Affairs - Informatics

The Director of Regulatory Affairs Informatics leads regulatory strategy and execution for software-enabled solutions, both device and non-device, across various medical domains like PACS, radiology, cardiology, pathology, urology, and virtual care. This role ensures compliance with global regulations including FDA and EU MDR, with a strong focus on cloud technologies, AI transformation, and the integration of third-party software throughout the product lifecycle. The director will also manage regulatory deliverables, drive process improvements, and serve as a key liaison with regulatory authorities.

Must Have

• Develop and implement global regulatory strategies for software-enabled medical devices.
• Oversee preparation and submission of regulatory filings (e.g., FDA pre-submissions, IDE, 510(k), EU MDR Technical Files/Design Dossiers).
• Partner with R&D, Quality, Clinical, and Product teams to integrate regulatory requirements.
• Evaluate and manage regulatory implications of integrating third-party software and cloud services.
• Manage regulatory deliverables and continuous improvement in strategic projects.
• Monitor and interpret evolving global regulations (FDA, EU MDR, MDD, MedDev, MDCG, QMS, cybersecurity, labeling, safety risk management standards).
• Serve as primary liaison with regulatory authorities and represent the organization in audits/inspections.
• 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 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.

Good to Have

• 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.

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.
• Regulatory project management : managing regulatory deliverables and continuous improvement in strategic projects while working with high performing global cross functional teams.
• 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.

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About Us

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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