Central Business Solutions Inc.
Business Analyst
Central Business Solutions Inc., Princeton, New Jersey, us, 08543
Position Role/Title:
Business AnalystLocation:
Princeton, NJ.Job DescriptionPerform regulatory activities for transferring recently CE marked products under Council Directive 93/42/EEC to compliance with MDR 2017/745.Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as assigned.Provide regulatory support for New Project Development projects as assigned with focus on CE marking and US requirements (510(k)).Provide regulatory support for Life Cycle Management project as assigned.Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.Perform Regulatory Change assessments as assigned.Experience in software validation IQ, OQ and PQ's, preferably Medtech or Healthcare.Review and approve system validation documents and assure regulatory compliance, GxP guidance documents and alignment with company SOPs.Review validation documentation for adherence to computer system validation (CSV) protocols, and applicable industry accepted standards.Ability to independently assess and monitor the project validation deliverables compliant to company procedures.Ensure adherence to the SDLC and IT Change Management processes for IT implementations.Collaborate with Business SMEs, IT and vendor partners to ensure alignment of business requirements and functional designs for implementation.Report or provide information in response to adhoc information requests.Act as the primary liaison between the end user and the software implementation team.Skills:Software Implementation, Software Consulting, Software End User Training, Software Configuration Management, (ISO 9001, ISO 13485, QSR), Medical Device Regulation (2017/745), EU MDR, GSPR, Medical Device Directive (93/42/EEC), FDA (US CFR), IQ, OQ and PQ's, preferably Medtech, GxP, SDLC, Agile.
#J-18808-Ljbffr
Business AnalystLocation:
Princeton, NJ.Job DescriptionPerform regulatory activities for transferring recently CE marked products under Council Directive 93/42/EEC to compliance with MDR 2017/745.Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as assigned.Provide regulatory support for New Project Development projects as assigned with focus on CE marking and US requirements (510(k)).Provide regulatory support for Life Cycle Management project as assigned.Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.Perform Regulatory Change assessments as assigned.Experience in software validation IQ, OQ and PQ's, preferably Medtech or Healthcare.Review and approve system validation documents and assure regulatory compliance, GxP guidance documents and alignment with company SOPs.Review validation documentation for adherence to computer system validation (CSV) protocols, and applicable industry accepted standards.Ability to independently assess and monitor the project validation deliverables compliant to company procedures.Ensure adherence to the SDLC and IT Change Management processes for IT implementations.Collaborate with Business SMEs, IT and vendor partners to ensure alignment of business requirements and functional designs for implementation.Report or provide information in response to adhoc information requests.Act as the primary liaison between the end user and the software implementation team.Skills:Software Implementation, Software Consulting, Software End User Training, Software Configuration Management, (ISO 9001, ISO 13485, QSR), Medical Device Regulation (2017/745), EU MDR, GSPR, Medical Device Directive (93/42/EEC), FDA (US CFR), IQ, OQ and PQ's, preferably Medtech, GxP, SDLC, Agile.
#J-18808-Ljbffr