Regulatory lead role
Regulatory lead role
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
