Regulatory Affairs Data Coordinator

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 currently seeking an RA Data Coordinator for a long-term engagement in Irvine, CA with one of our Global clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

JOB SUMMARY

The Regulatory Affairs Data Specialist I supports the collection, maintenance, analysis, and reporting of regulatory data to ensure accuracy, compliance, and operational efficiency. This role partners with cross-functional teams to develop reports, dashboards, and data-driven insights that support product registrations, regulatory submissions, and lifecycle management activities. The position also supports the preparation and maintenance of regulatory submission documentation, product registrations, and regulatory assessments to help ensure compliance with global regulatory requirements.

DUTIES & RESPONSIBILITIES

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

For all positions:

• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

EXPERIENCE AND EDUCATION

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Biomedical Sciences, Information Systems, Data Analytics, or a related field.
• 0-3 years of experience in Regulatory Affairs, Quality, Data Analytics, Medical Devices, or a related regulated industry.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/ LICENSES and AFFILIATIONS

• 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.