Business Analyst - Princeton, United States - Central Business Solutions

Central Business Solutions Princeton, United States

4 days ago

Description

Position Role/Tile:
Business Analyst

Location:
Princeton, NJ.

Job Description

Perform 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

Central Business Solutions, Inc,

37600 Central Ct.

Suite #214

Newark, CA

Central Business Solutions, Inc(A Certified Minority Owned Organization)

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Central Business Solutions, Inc

37600 Central Court Suite 214 Newark CA, 94560

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