Senior International Regulatory Affairs Specialist
Core
Enable global market access for innovative hardware and software medical devices by executing regulatory strategies and managing international submissions.
Role type
Senior International Regulatory Affairs Specialist
Builds
Global regulatory pathways for Class II+ medical devices and Software in a Medical Device (SiMD)
Domain
Medical device industry, international regulatory compliance
Deliverable
client delivery
Required skills
International regulatory submissions, EU MDR 2017/745, MDSAP, APAC/MEA/LATAM market access, Software in a Medical Device (SiMD), Quality Management System (QMS), change control, design control, lifecycle management, regulatory impact assessment, document management systems
Preferred skills
Advanced degree, experience with Software as a Medical Device (SaMD), familiarity with ISO 13485/ISO 14971/IEC 62304
Technologies
document management systems, regulatory submission platforms, tracking tools
Responsibilities
Execute global regulatory strategies for Class II and higher medical devices; coordinate international regulatory submissions across APAC, MEA, LATAM, and MDSAP countries; prepare and manage regulatory submission documentation; maintain product registrations, renewals, and amendments; partner with cross-functional teams to align regulatory requirements with product development; assess regulatory impact of product and software changes; coordinate with regulatory authorities and notified bodies; support post-market regulatory activities including renewals and audit readiness
Seniority
Senior, hands-on IC