Director of Regulatory Affairs Informatics
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Monthly Salary:
Posted on:
07-11-2025
Vacancies:
1 Vacancy
Job Summary
Job Title
Director of Regulatory Affairs - InformaticsJob 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.
Youre the right fit if:
- Masters 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 isnt 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 companys facilities.
Field roles are most effectively done outside of the companys 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 wont 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 youre 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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Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
