Regulated Life Sciences Project Manager

Organ Recovery Systems, Inc.; Itasca (IL); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Annual Incentive Bonus

Comprehensive Medical, Dental & Vision

Company‑Paid Life Insurance

Short‑Term & Long‑Term Disability

Flexible Spending Accounts

Generous Paid Time Off

Summer Hours Program

Tuition Reimbursement & Professional —

Employee Assistance Program

Pet Insurance & Identity Protection

Wellness Reimbursement

STEM Scholarship Program

Job summary

Organ Recovery Systems, Inc. in Itasca, IL is seeking a Project Manager to lead cross‑functional initiatives in an FDA‑regulated setting, driving concept‑to‑launch execution, coordinating teams, managing plans, schedules, budgets, risks, and deliverables to align with business and regulatory expectations.

The role requires strong communication, organizational and stakeholder‑management skills, with proficiency in project tools (Smartsheet preferred).

Qualifications

• 5+ years of project and/or program management experience within medical device, pharmaceutical, biotechnology/biologics, diagnostics, or other FDA‑regulated life sciences industries.
• Experience with regulatory processes such as Regulatory Compliance, GMP, Quality Systems, Design Controls, Product Development, Manufacturing, Validation, or Commercialization.
• Experience leading projects or workstreams requiring strong communication, organization, stakeholder engagement, and accountability for results.
• Experience supporting cross‑functional teams, project schedules, risk management, action item tracking, and project documentation preferred.
• Experience supporting project financial processes, including purchase orders, vendor coordination, and invoice tracking.

Responsibilities

• Drive project execution from concept through launch, coordinating cross‑functional teams and managing plans, schedules, budgets, risks and deliverables.
• Ensure alignment with business objectives and regulatory expectations.
• Proficient with project management tools; Smartsheet experience highly preferred for project visibility.
• Organize project meetings, assign action items, track progress, and provide status reports to the Manager, PMO and sponsors.
• Manage day‑to‑day project activities and resource coordination; escalate roadblocks when needed.

Skills

Project management

Cross-functional collaboration

Regulatory knowledge

Communication

Stakeholder management

Smartsheet

Microsoft Project

Education

Bachelor’s degree in Science/Engineering/Business/Project Management

Tools

Smartsheet

Microsoft Project

SharePoint

Microsoft Excel

Job description

Organ Recovery Systems, Inc. in Itasca, IL is seeking a Project Manager to lead cross‑functional initiatives in an FDA‑regulated setting, driving concept‑to‑launch execution, coordinating teams, managing plans, schedules, budgets, risks, and deliverables to align with business and regulatory expectations.

The role requires strong communication, organizational and stakeholder‑management skills, with proficiency in project tools (Smartsheet preferred).