Gap Assessment/Regulatory Lead \u2013 Medical Devices

Roles & Responsibilities:

• Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience

• \u2018Bachelor 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, particular 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.

Required Skills (Technical Competency):

• 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.

• 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.