Regulatory Affairs Data Coordinator

Kelly Services; Irvine (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K

Paid time off

Holiday pay

Job summary

Kelly Science & Clinical is seeking an RA Data Coordinator I for a long-term Irvine, CA engagement with a global medical device client. You will support collection, maintenance, and reporting of regulatory data to enable registrations and submissions, with cross-functional dashboards and analytics.

As part of Kelly FSP, you’ll work full-time with comprehensive benefits, participate in process improvements, and partner with Regulatory Affairs to drive data accuracy and lifecycle compliance across

Qualifications

• 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.
• 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.

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
• As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

Skills

Data analysis

Excel

Power BI

SharePoint

Regulatory databases

Education

Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Biomedical Sciences, Information Systems, Data Analytics, or related field

Tools

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 Medical Device 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affluent Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.