Regulatory Lead

Company Description

• Katalyst Health cares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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.
• Ability to take initiatives and drive the project to completion.
• Lead team effectively and work closely with customers.

All your information will be kept confidential according to EEO guidelines.