Regulatory Data Analyst - Global Submissions & Dashboards

Kelly Science, Engineering, Technology & Telecom; Irvine (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Kelly Science and Clinical FSP is seeking an RA Data Coordinator for a long-term Irvine, CA engagement. You will support collection, maintenance, analysis, and reporting of regulatory data to enable registrations and submissions.

The role partners with Regulatory Affairs to develop data-driven reports and dashboards, and to maintain regulatory submission documentation for global requirements. The position supports lifecycle management activities and drives continuous improvement to comply with

Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Biomedical Sciences, Information Systems, Data Analytics, or related field.
• 0-3 years of experience in Regulatory Affairs, Quality, Data Analytics, Medical Devices, or related regulated industry.
• Strong analytical and problem-solving skills with attention to detail.
• Proficiency in Microsoft Office applications, particularly Excel, Power BI, SharePoint, and regulatory databases and reporting platforms tools.
• Ability to organize and manage multiple priorities in a fast-paced environment.
• Strong written and verbal communication skills.
• Ability to work effectively in cross-functional and global teams.

Responsibilities

• Research and coordinate data collection and verification to ensure accuracy in Regulatory Information Management (RIM) Systems.
• Monitor data quality, compliance, and timely remediation.
• Partner with Regulatory Affairs team members to support data needs.
• Provide data reporting, analysis, and interpretation of RIM data into metrics, reports, and dashboards.
• Support audit and inspection activities by retrieving regulatory information.
• Liaise between business process owners, IT, and Analytics teams and provide training to Regulatory Affairs team.
• Support submission documentation collection to aid product registration and changes for various countries.
• Drive continuous improvement to ensure compliance with company standards and regulatory requirements.
• Communicate critical issues to client management and Analytics teams.
• May be responsible for other Regulatory activities as needed.

Skills

Analytical skills

Attention to detail

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in Regulatory Affairs / Life Sciences / Engineering / Biomedical Sciences / Information Systems

Tools

Excel

Power BI

SharePoint

Regulatory databases

Job description

Kelly Science and Clinical FSP is seeking an RA Data Coordinator for a long-term Irvine, CA engagement. You will support collection, maintenance, analysis, and reporting of regulatory data to enable registrations and submissions.

The role partners with Regulatory Affairs to develop data-driven reports and dashboards, and to maintain regulatory submission documentation for global requirements. The position supports lifecycle management activities and drives continuous improvement to comply with