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Business Analyst

Princeton, NJ
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 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
Checkout our excellent assessment tool: http://www.skillexam.com/
Checkout our job board : http://www.job-360.net/
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677
Web: http://www.cbsinfosys.com
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