Regulatory lead role
Regulatory lead role
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- 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.
- 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.
Employment Type
Full Time
