Regulatory Affairs Officer
Core
Strategic architect for global regulatory expansion of AI-driven breast cancer screening software across APAC, LATAM, Middle East, and Africa.
Role type
Senior Regulatory Affairs Officer (Medical Device/AI)
Builds
Global regulatory submissions and market access strategies for Transpara Breast AI
Domain
Medical Devices / Artificial Intelligence / Oncology
Deliverable
client delivery
Required skills
Global regulatory submissions, International market registration, Regulatory strategy, Process optimization, Regulatory intelligence, Stakeholder management
Preferred skills
Software as a Medical Device (SaMD), IEC 62304, ISO 14971, AI/cybersecurity frameworks, US/EU submissions (510k, de Novo, PMA, EU MDR), Cloud/SaaS, Notified Body interaction, Breast radiology workflows
Technologies
510(k), de Novo, PMA, EU MDR, IEC 62304, ISO 14971
Responsibilities
Lead global submissions and registrations for new and existing products, Advise on strategic market access and launch timing, Streamline regulatory processes for reuse of documentation, Monitor global regulatory landscape and advise engineering teams, Act as primary contact for external partners and internal teams
Seniority
Mid-Senior, hands-on IC
