Senior Regulatory Affairs Specialist
Core
Drive regulatory strategies and ensure compliance for Philips CT/AMI medical imaging products across global markets.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions, technical documentation, and market expansion strategies for hardware systems.
Domain
Medical Devices / Imaging Hardware
Required skills
510(k) submission, CE Mark/EU MDR compliance, IEC 60601, IEC 62304, ISO 14971, risk management, Notified Body interaction, lifecycle management, stakeholder leadership.
Preferred skills
SaMD (IEC 82304), international regulatory standards (FDA, Health Canada, Japan), RAPs RAC certification.
Technologies
IEC 60601, IEC 62304, ISO 14971, IEC 82304
Responsibilities
Lead global regulatory strategies for market expansion; prepare and review EU MDR Technical Documentation; partner with engineering on system-level risk management and validation; support international submissions and renewals; act as interface during audits; mentor regulatory teams.
Seniority
Senior, hands-on IC with mentorship