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Philips

Clinical Informatics Regulatory Lead

Philips

. Lead global Regulatory Affairs strategy and execution across the Clinical Informatics portfolio .

Posted 10/27/2026full-timeBangalore • IndiaSenior💰 €78,187 - €130,312 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in leading global Regulatory Affairs strategies and execution, particularly within the Clinical Informatics portfolio, while effectively collaborating with cross-functional teams and advising on regulatory risks and business decisions.

Highest-signal resume keywords
Regulatory Affairs ExperienceFDA KnowledgeEU MDR/IVDR ComplianceLeadership of Global Regulatory StrategiesExperience with SaMD and AI/ML Products

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory PathwaysSubmissionsMarket Access ActivitiesClinical InformaticsDigital PathologyCybersecurityInteroperabilityISO 13485ISO 14971MDSAP
Soft Skills
People LeadershipExecutive PresenceStakeholder Influence
Industry Keywords
Medical DevicesIVDsGlobal Regulatory FrameworksProduct ManagementClinical Teams

Tech Stack

Tools & technologies
CloudCyber Security

About the role

Key responsibilities & impact
  • Lead global Regulatory Affairs strategy and execution across the Clinical Informatics portfolio
  • Drive regulatory pathways, submissions, registrations, and market access activities worldwide
  • Partner with R&D, Quality, Clinical, Product Management, Cybersecurity, and Commercial teams on new products, software releases, AI/ML capabilities, and market expansions
  • Advise senior leaders on regulatory risk, timelines, and business decisions
  • Represent the company with FDA, notified bodies, competent authorities, and regulators globally
  • Build and develop a high-performing Regulatory Affairs organization

Requirements

What you’ll need
  • Strong knowledge of FDA, EU MDR/IVDR, ISO 13485, ISO 14971, MDSAP, and global regulatory frameworks
  • Significant Regulatory Affairs experience in medical devices and/or IVDs
  • Experience with SaMD, AI/ML-enabled products, cloud-connected solutions, cybersecurity, and interoperability
  • Proven leadership of global regulatory strategies and complex product portfolios
  • Experience in clinical informatics, digital pathology, radiology, oncology, urology, or diagnostic imaging preferred
  • Strong people leadership, executive presence, and stakeholder influence skills

Benefits

Comp & perks
  • 3% short term incentive linked to individual performance and company results
  • Hybrid working
  • Paid time-off
  • Health and wellbeing benefits
  • Learning and development opportunities