Regulatory Affairs Data Coordinator

Remote in Irvine, CA, US • Posted 1 hour ago • Updated 1 hour ago
Contract W2
On-site
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Job Details

Skills

  • Operational Efficiency
  • Lifecycle Management
  • Research
  • Data Collection
  • Information Management
  • Data Quality
  • RIM
  • Visualization
  • Dashboard
  • Auditing
  • Inspection
  • Business Process
  • Training
  • Documentation
  • Continuous Improvement
  • Analytics
  • Regulatory Compliance
  • Policies and Procedures
  • Life Sciences
  • Biomedicine
  • Science
  • Information Systems
  • Regulatory Affairs
  • Data Analysis
  • Medical Devices
  • Analytical Skill
  • Conflict Resolution
  • Problem Solving
  • Attention To Detail
  • Microsoft Office
  • Microsoft Excel
  • Microsoft Power BI
  • Microsoft SharePoint
  • Database
  • Reporting
  • Management
  • Communication

Summary

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 Coordinator 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.
SECTION 4: 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10105282
  • Position Id: 884116
  • Posted 1 hour ago

Company Info

About Motion Recruitment Partners, LLC

Motion Recruitment delivers IT Talent Solutions for Contract, Direct Hire, Managed Solutions and Statement of Work to all of North America from our 21 delivery centers. Our high-touch, specialized, team-based recruitment model’s success is proven through our exemplary track record in filling the most challenging IT positions for startup and enterprise clients alike. Our hyper-specialized tech focus results in a truly consultative approach for both our clients and candidates, within our recruiting areas of expertise: Software, Mobile, Data, Infrastructure, Cybersecurity, Product + UX and Functional.

Motion also delivers IT Consulting Solutions through the Motion Consulting Group (MCG) that create true digital transformation for IT projects in Agile Development & Coaching, DevOps & DevSecOps Solutions, and Managed Services for IT Operations.

We’re also the proud creators of Tech in Motion and the Timmy Awards, our North American community platform, events series and award program that connects over 250,000 tech enthusiasts to meet, learn, and innovate.

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