Regulatory Affairs Engineering Lead, Clinical Evaluation
Core
Lead clinical evaluation and regulatory submissions for a medical device generating its own clinical evidence, ensuring compliance across FDA, EU MDR, and UK MDR frameworks.
Role type
Regulatory Affairs Engineering Lead (Clinical Evaluation)
Builds
Clinical evaluation plans, reports, investigation protocols, and technical file clinical sections for regulatory submissions
Domain
Medical Devices / Health Technology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical evaluation methodology (MEDDEV 2.7/1 Rev 4, MDCG), Clinical investigation design (ISO 14155), Regulatory strategy development, Submission preparation, Risk-based compliance assessment, Cross-functional guidance on hardware/software standards
Preferred skills
Post-market clinical follow-up (PMCF) planning, Wearables/imaging/screening device experience, ISO 13485 QMS integration, Mentoring on regulatory topics
Technologies
ISO 14155, EU MDR, FDA 21 CFR, UK MDR 2002, IEC 62304, IEC 60601-1, IEC 62366-1, ISO 14971
Responsibilities
Author clinical evaluation plans and reports, own clinical study/investigation regulatory aspects, build regulatory strategy for clinical evidence, prepare submissions and maintain technical file clinical sections, provide regulatory guidance on device standards, assess impact of device changes, own post-market surveillance and clinical follow-up, deliver training, support audits
Seniority
Senior, hands-on IC
