Regulatory Project Coordinator

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 elevate concerns as needed

Support the preparation, coordination, and submission of regulatory documentation for global product registrations

Maintain transparency of project status, including risk, 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

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