Roles & Responsibilities:
- Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience
- Bachelor of Engineering / Diploma in Mechanical or equivalent
- 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 IQOQ & PQ
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.