Join Kelly FSP as a RA Data Specialist on site with our Medical Device client in Irvine, CA!

We are currently recruiting for a Regulatory Affairs Data Specialist to support the Regulatory Affairs team, located in Irvine, CA.

The Regulatory Affairs Data Specialist will execute regulatory activities to support Regulatory Systems for our client. This role involves a multi-faceted set of skills including cross-functional collaboration and planning/oversight/execution of projects & activities that directly impact the operational results of the business.

Position Duties & Responsibilities

Researches and coordinates data collection across the company to support the Regulatory Affairs Lead

Performs and manages data entry activities

Liaison between our client companies and Systems, Processes, and Analytics team to provide support and training

May be responsible for other Regulatory activities as needed

Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations

Communicates critical issues to Management

Qualifications

A minimum BA/BS Degree with at least 2+ years of regulated medical device industry experience (or related) required

Strong Systems skills and comfort in information technology is required

Must be proficient with MS Office applications; specifically Excel and SharePoint

Excellent written and oral communication skills is required

Ability to handle multiple tasks and be detail oriented is required