Regulatory lead role

Responsibilities:Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience.Bachelor of Engineering / Diploma' in Mechanical or equivalent.Knowledge of Design History file, Device History Record and Device Master Record documents.Proficiency in Project management and execution.3-6 years of experience in DHF gap analysis / remediation for medical devices.Strong hold on medical device lifecycle knowledge starting from PRS/DRS preparation till Verification and Validation testing and traceability mapping.Expertise in drafting / reviewing Risk Management plan & reports (RMP & RMR) as per ISO 14971.QMS compliance management as per ISO 13485.Hands-on experience in mechanical design – part design, sub-system design including GD&T and tolerance stack up as per industry standards.Knowledge of FMEA (Design, Process, System.)Knowledge of DHF and DMR preparation.Sound Regulatory knowledge: IEC 60601-1, MDR 2017/745 or MDR 2017/746, QSR per 21 CFR Part 820, standards, collateral standards, etc.Experience in Regulatory and V&V is preferred.Shall have good knowledge on manufacturing and assembly including process validation – IQ, OQ & PQ.Experience in process engineering is an added advantage with knowledge of drafting SOPs, Work instructions, etc.Requirements:Work experience of Gap Assessment of Class II & Class III Devices.Experience in Sustenance activities in medical products/ Healthcare business desired.Good knowledge of ISO 13485 QMS, Risk Management, IEC Standards (General Safety, Particular & Collateral) and MDR.Work experience with Verification and Validation testing is an added advantage.Ability to take initiatives and drive the project to completion.Lead team effectively and work closely with customers.