What are the responsibilities and job description for the Regulatory Lead position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & 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.
Job Description
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.
Additional Information
All your information will be kept confidential according to EEO guidelines.