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Company: HCL America, Inc.
Location: Santa Clara, CA and various unanticipated locations throughout the U.S.
Job Title: Lead – Regulatory Affairs (HCLA49)
Multiple positions available

Job Description:

Provide regulatory expertise and guidance on procedural and documentation requirements. Knowledge of global medical device regulatory requirements. Support clients in getting marketing authorization of Invitro diagnostic devices to European and global markets to ensure continued availability of safe and essential diagnostic devices to users. Knowledge of the newly introduced regulatory requirement of European Union Regulation. Help clients in transitioning to meet the regulatory requirements for CE marking of Invitro diagnostic devices by preparing all the required documents as per the EU IVDR 2017/746 (mandate for all Invitro diagnostic devices by 2022 or 2025 depending on risk classification of the devices to sustain in market). Regulatory review of performance study plans for FDA resubmissions and clinical study planning. Evaluate clinical performance studies of Invitro Diagnostic Medical devices as per regulatory requirements or guidelines to test the safety and performance of the medical devices and write clinical performance reports. Knowledge of CLSI standards; EP05, EP07, EP09, EP10, EP12, EP21, EP25 and analytical performance requirements of invitro diagnostic devices to demonstrate the performance of the device. Review scientific literature and prepare scientific validity reports for individual assays. Review of IVD products as per regulations (FDA IVD Regulations, (EU) 2017/746 -IVDR) and ensure that quality standards are met and submissions meet regulatory guidelines. Provide regulatory expertise and guidance on procedural and documentation requirements.

Job Requirements:

Requires Master’s degree or foreign equivalent in Computer Science, Engineering (Any), Information Technology, Computer Technology, Computer Information Systems, Management Information Systems, Physiology, or related field plus one (1) year of experience in the job offered, or related IT or engineering role. Will accept a Bachelor’s degree plus five (5) years of described experience in lieu of Master’s degree plus one (1) year of described experience. Any suitable combination of education, training, or experience is acceptable. Base Salary: $125,715 - $127,000 (whatever range we reasonably expect to hire a candidate within based upon our internal salary grid). Exact compensation may vary based on skills, experience, education, and/or to comply with federal or state law. Travel and work at client sites as assigned.

How to apply: Email resume, referencing HCLA49, including job history, to: HanimireddyV@hcl.com/Priti-Gokhale@hcl.com. HCL America, Inc.is an Equal Opportunity Employer.