Senior IVD Program Lead – Remote

Meridian Bioscience Inc.; United States; Remote; USD 95,000 - 140,000; Full time

Job summary

Meridian Bioscience Inc. seeks an experienced Senior Project Manager to lead complex, cross-functional new product development projects for in vitro diagnostic assays and instrument systems within an FDA-regulated medical device environment.

The role covers project planning and execution from concept through launch, with emphasis on design control compliance, schedule, risk, resources, budgets, dependencies, and timely decisions. Remote work options may apply with travel as required.

Qualifications

• Bachelor’s degree in science, engineering or business administration required.
• At least 7 years of project management experience leading cross-functional product development projects.
• Direct experience managing FDA-regulated IVD product development projects.
• Proven track record of leading IVD products through FDA clearance or approval.
• Strong knowledge of medical device design control and product development processes.
• Travel up to 20%.

Responsibilities

• Define project scope, goals, deliverables, success criteria, and governance for complex product development projects.
• Develop and maintain integrated project plans with critical path and resources.
• Proactively identify risks and issues and recommend changes to meet objectives.
• Track performance and provide status, forecasts, and escalations to leadership.
• Ensure on-time completion of deliverables in line with design controls.
• Lead cross-functional project teams and external partners to decision making.
• Other duties as assigned.

Skills

Project management

Cross-functional leadership

FDA regulated IVD

Schedule management

Risk management

Communication

Strategic thinking

Education

Bachelor’s degree in science, engineering or business administration

Advanced degree preferred

Job description

Meridian Bioscience Inc. seeks an experienced Senior Project Manager to lead complex, cross-functional new product development projects for in vitro diagnostic assays and instrument systems within an FDA-regulated medical device environment.

The role covers project planning and execution from concept through launch, with emphasis on design control compliance, schedule, risk, resources, budgets, dependencies, and timely decisions. Remote work options may apply with travel as required.