Urgent Need || Regulatory IT BA || Memphis, TN (GC/USC)

Title: Regulatory IT BA
Position Type: Right to Hire
Location: Memphis, TN, United States
Description:

Duration: 6 month CTH
Visa: GC/USC

Ideally female due to most of the team being female
needs to be senior level
Med Device background required with BI experience ideally
 

Regulatory IT BA

• Scope
  • The QRA Business Systems Analyst works to implement and maintain IT systems within the Quality, Regulatory, and Clinical Affairs groups of a regulated medical device manufacturer. This role will work with Project Managers, System Architects, and Service Delivery Managers to deliver IT systems in support of medical device manufacturing operations.
  • The right candidate will be excited to support business processes with solid experience in both quality/regulatory affairs workflows and a broad technical understanding of IT implementation practices.

 

• Core Requirements
  • Working between business partners to define business needs and to translate requirements into functional systems
  • Understanding the business landscape to effectively coordinate information outreach between multiple business and IT divisions worldwide
  • Development of Business Requirements Documents
  • Development of Integration Testing, UAT, and other Validation/Traceability documentation as required
  • Experience in Quality, Regulatory Affairs, and Clinical Affairs workflows and practices in a regulated medical device manufacturing environment
  • Definition and development of business analytics/reporting as part of system delivery
  • Other duties as assigned
• Preferred Experience
  • Understanding of business analytics/project management methodologies and terminologies (ITIL, PMP)
  • Understanding of SAP transactions and data models
  • Experience with Microsoft 365 business tools, including SharePoint, PowerApps, DAX, Forms, and Power Automate
  • Understanding of data flows transformation (Ability to read SQL, developing architectural models, and ability to assist with system functional specifications as needed)
  • Experience with common data and visualization tools: Marklogic, TIBCO Spotfire, Power BI

 

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Thanks & Regards

Shailbi Shukla

Recruitment & IT Solutions Inc.

Email To: shailbishukla@gmail.com
Fax :(703) 852 – 7939

8230 Boone Blvd, Suite 403, Vienna, VA 22182

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