Regulatory Operations Specialist

Location: Irvine, California
Posted On: 3/14/2017
Job Code: ROS_CA2128
Job Description
Reviewing Documentation, Saving to Sharefolder, updating internal tracker
Ordering Food/Snacks
Ordering Office Supplies
Taking meeting Minutes, distributing to meeting attendees
Assist with edits/cleanup on Process SOPs/Work Instructions after drafted into final versions
Ad hoc project work; Sharefolder cleanup, drafting cheat sheets for the team, updating guideline spreadsheets with information
GTS / SAP Activities - Function as back-up and a local expert for all SAP/GTS issues, processes, team support and training. This will include managing any blocked order issues and conducting any needed investigations or assessments to keep the product distribution active. Participate on all SAP/GTS business and corporate teams as assigned. Provide guidance and problem solving assistance in SAP/GTS related issues.
• Coverage of GTS for Neurovascular Products
• Contribute to the development of the processes and procedures for all Operational functions
• Contribute to the development of systems and data associated with Regulatory Functions, process improvement, system integrations, system implementations, system development work
• Contribute to the development of robust reporting to support our Regulatory Affairs and Regulatory International teams, and executives
• High attention to detail, highly skilled in task management, task oriented
• Ability to solve problems and provide solutions
• Flexible with priorities and responsibilities
• Works well under pressure in a dynamic environment
• Effective organizational skills
• Strong work ethic
• Works well under pressure in a dynamic environment
• General knowledge of industry practices, techniques and standards
• Intermediate/Advance knowledge of word processing, spreadsheet/graphing, including knowledge of MS Office applications, including Word, Excel, PowerPoint.
• Experience in a regulatory affairs, either in regulatory product specialist, regulatory international or regulatory operations role.
• Working knowledge of document management systems (e.g. Agile, RAD, Documentum)
• Working knowledge or experience in regulatory submission work
• SAP experience
• Project work associated with SDLC, Data Warehousing, Data and Process Improvement
3+ years of experience in related field
Category:IT  code:new
Job Requirements
Training, MS Office, MS Word, Management, Documentum, SDLC, MS Excel, SAP

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Contact Details
Ebrahim Sayarwala