Compliance Engineer
Core
Ensure Software as a Medical Device (SaMD) and health software applications meet regulatory, safety, and cybersecurity standards.
Role type
Compliance Engineer (SaMD)
Builds
SaMD and health software applications
Domain
Health technology / Medical devices
Deliverable
client delivery
Required skills
Risk management planning, audit execution, regulatory gap analysis, traceability matrix management, QMS procedure updates, third-party library evaluation, SDLC understanding
Preferred skills
Medical device regulations knowledge, clinical workflow understanding, technical report writing
Technologies
ISO 13485, EU MDR, MDSAP, HDS, SOC 2, HITRUST
Responsibilities
Serve as SME during internal and external audits, Develop Risk Management Plans and perform safety/cybersecurity risk analyses, Manage product requirement specifications and maintain traceability matrices, Lead technical design reviews for new product introductions, Prepare comprehensive release documentation, Conduct post-market risk assessments, Evaluate third-party software libraries, Perform gap analyses against regulations, Update and improve Quality Management System (QMS) procedures
Seniority
Mid-level, hands-on IC
