Compliance Specialist

Regulatory and Compliance EngineerLocation: Plano, TX (Onsite)Note: If you are not comfortable to receive call, don't Apply,HCL AmericaContract: 6-12+ month Visa: Visa independent**Update LinkedIn ID RequiredRequired skills:Min 2-4 years of experience in Regulatory and compliancePrior experience with medical device compliance testing highly desiredExperience working with regulatory standards and external testing labs requiredMedical device compliance and regulatory testingTest plan development and reportingStandards and regulation analysisDocumentation control and release processesCross functional collaboration with test houses and internal teamsRadio / Wireless: • EN 300 328 • FCC 15.247 • EN 301 489 1 / EN 301 489 17Implantable Devices: • ISO 14708 1 • ISO 14708 3 • Non-Implantable Medical Devices: • IEC 60601 1 • IEC 60601 1 2 • EMC / Immunity: • IEC 61000 4 series