Katalyst Healthcares and Life Sciences
Regulatory Lead
Katalyst Healthcares and Life Sciences, Minneapolis, Minnesota, United States, 55400
Responsibilities:
Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience. 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:
Bachelor of Engineering / Diploma' in Mechanical or equivalent. 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. bility to take initiatives and drive the project to completion. Lead team effectively and work closely with customers.
Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience. 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:
Bachelor of Engineering / Diploma' in Mechanical or equivalent. 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. bility to take initiatives and drive the project to completion. Lead team effectively and work closely with customers.