Senior Compliance Engineer
Core
Ensures Abbott Neuromodulation products comply with medical device safety, EMC, wireless, and environmental regulatory standards throughout the product lifecycle.
Role type
Senior Compliance Engineer (Medical Devices)
Builds
Safe and compliant medical device solutions for patients with chronic pain and movement disorders
Domain
Healthcare / Medical Devices / Regulatory Compliance
Required skills
Product compliance strategy, standards interpretation, test plan development, impact assessment, root cause analysis, regulatory submissions, cross-functional collaboration
Preferred skills
Class II/III medical device experience, IEC 60601 series knowledge, wireless/EMC evaluation, implantable device systems, standards revision assessment
Technologies
IEC 60601, ISO 14708, IEC 62304, ISO 10993, FCC, RED
Responsibilities
Evaluate product designs against national and international standards; develop compliance strategies and test protocols; partner with external labs for certifications; conduct impact assessments for design changes; monitor regulatory revisions; investigate compliance issues and develop corrective actions
Seniority
Senior, hands-on IC