Regulated Medical Device Project Manager

Organ Recovery Systems, Inc.; Itasca (IL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual Incentive Bonus

Medical, Dental & Vision Coverage

401(k) with Company Match

Generous Paid Time Off

Tuition Reimbursement

Job summary

Organ Recovery Systems is seeking a Project Manager to lead cross‑functional, FDA‑regulated initiatives from concept to launch. You will drive schedules, budgets, dependencies, and stakeholder alignment in a fast‑paced environment.

The ideal candidate has 5+ years in regulated product development, GMP/Design Controls exposure, and strong communication skills. Smartsheet expertise and proficiency with MS Project/SharePoint are highly valued. This role is based in Itasca, IL.

Qualifications

• Bachelor’s degree in Science, Engineering, Business, Project Management, or related field.
• 5+ years of project/program management in FDA-regulated life sciences.
• Experience with Regulatory Compliance, GMP, Quality Systems, Design Controls, Product Development.
• Strong communication, organization, stakeholder engagement and accountability.
• Proficiency with PM tools; Smartsheet preferred.

Responsibilities

• Manage assigned company projects, schedule meetings, align stakeholders, track actions and budgets.
• Organize project communication and documentation; coordinate cross‑functional activities.
• Create and maintain project plans, milestones, timelines, and risk mitigation; manage resources.

Skills

Project management

Regulatory compliance

Cross‑functional teams

Communication

Smartsheet

Education

Bachelor’s degree in Science/Engineering/Business/PM

Tools

Smartsheet

Microsoft Project

SharePoint

Microsoft Excel

Job description

Organ Recovery Systems is seeking a Project Manager to lead cross‑functional, FDA‑regulated initiatives from concept to launch. You will drive schedules, budgets, dependencies, and stakeholder alignment in a fast‑paced environment.

The ideal candidate has 5+ years in regulated product development, GMP/Design Controls exposure, and strong communication skills. Smartsheet expertise and proficiency with MS Project/SharePoint are highly valued. This role is based in Itasca, IL.