Job Requirements

A regulatory affairs specialist is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under certain regulations.

Work Experience

Roles & 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, 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 desiredGood knowledge of ISO 13485 QMS, Risk Management, IEC Standards (General Safety, Particular & Collateral) and MDRWork 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.