Principal Specialist, Regulatory Affairs
Core
Provide regulatory support for on-market medical device products, managing change assessments, variation planning, and global submission documentation.
Role type
Principal Specialist, Regulatory Affairs
Builds
Regulatory submission deliverables for sustaining variations and product changes
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory impact assessment, global submission planning, FDA regulations, MDR, ISO/IEC design control procedures, risk analysis, FMEA, document control, cross-functional collaboration
Preferred skills
Engineering background (Bio-medical, Electrical, Electronics, Software, Mechanical, Industrial), multi-project delivery, compliance risk identification
Technologies
FDA, ISO, IEC, IDE, PMA, 510(k), EU Design Dossiers, Technical Files, Canadian Device License Applications
Responsibilities
Review and provide regulatory impact assessments for changes; Support global submission deliverables for product variation submissions; Execute global plans and regulatory submission deliverables for sustaining variations; Ensure identified standards and content requirements are met for regulatory submissions; Timely, actively support query responses; Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s); Review, edit and proofread regulatory documentation; Assist with the writing and coordination of regulatory submissions for both, developed and emerging countries/regions, including original IDE, original PMA, and 510(k) submissions and supplements, EU Design Dossiers and Technical Files, Canadian Device License Applications, etc.
Seniority
Senior, hands-on IC with mentorship responsibilities