Regulatory Project Coordinator

Regulatory Project Coordinator

8-month contractor

Onsite in Des Plaines, IL

Key Responsibilities:

• Collaborate with cross-functional teams to create and manage regulatory submission project plans and timelines
• Monitor progress of submission deliverables and ensure accountability across stakeholders
• Identify, communicate, and help resolve risks and issues that may impact project timelines or quality
• Develop and implement mitigation strategies for critical path activities and escalate concerns as needed
• Support the preparation, coordination, and submission of regulatory documentation for global product registrations
• Maintain transparency of project status, including risks, dependencies, and milestones
• Contribute to the development and maintenance of efficient, compliant regulatory processes and workflows
• Provide operational support to ensure adherence to regulatory standards and internal procedures

Qualifications:

• ~3–5 years of experience in regulatory operations, regulatory project management, or submission coordination
• Understanding of regulatory submission processes, requirements, and timelines
• Familiarity with global regulatory guidelines, policies, and standards
• Experience supporting domestic and international submission/registration activities
• Knowledge of In Vitro Diagnostic (IVD) regulations, including applicable FDA and/or international requirements
• Ability to identify and manage project risks and support issue resolution
• Strong organizational, communication, and cross-functional collaboration skills