Gap Assessment/Regulatory Engineer \u2013 Medical Devices

Roles & Responsibilities:

• Regulatory / V&V / Quality Assurance Engineer with 3-8 Years of experience
• Minimum 3 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
• Knowledge of FMEA (Design, Process, System)
• Knowledge of Design History file, Device History Record and Device Master Record documents
• 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, particular standards, collateral standards, etc.
• Experience in Regulatory and V&V is preferred.
• Experience in process engineering is an added advantage with knowledge of drafting SOPs, Work instructions, etc.

• 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 customer.