Remote Project Manager, FDA-Regulated IVD & NPD

Meridian Bioscience International Limited; Cincinnati, Northern (OH, KY); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Meridian Bioscience International Limited seeks a Project Manager to lead cross-functional new product development projects for FDA-regulated IVD assays and instrument systems. The role covers planning, execution, and compliance from concept to launch, with travel as required and potential remote work options.

The position requires a Bachelor’s degree in science, engineering, or business and at least 5 years of PM experience in regulated medical device development. PMP is a plus.

Qualifications

• Bachelor’s degree in science, engineering or business required; advanced degree preferred.
• At least 5 years of project management experience leading cross-functional product development.
• Direct experience managing FDA-regulated medical device development projects.
• Knowledge of design control requirements and product development processes.
• Preferred: experience with IVD products and regulatory quality systems.
• Preferred: PMP or equivalent certification.

Responsibilities

• Lead cross-functional NPD projects from concept to launch in an FDA-regulated environment.
• Define scope, goals, deliverables, timelines and budgets with leadership alignment.
• Develop accurate project plans, track progress and communicate status.
• Ensure design control compliance and risk management throughout development.
• Facilitate cross-functional team meetings and decision-making.
• Travel as needed to support project milestones.

Skills

Project management

Cross-functional leadership

FDA-regulated

Design controls

Risk management

IVD products experience

PMP certified

Communication skills

Travel readiness

Education

Bachelor's degree in science/engineering/business

Advanced degree preferred

Job description

Meridian Bioscience International Limited seeks a Project Manager to lead cross-functional new product development projects for FDA-regulated IVD assays and instrument systems. The role covers planning, execution, and compliance from concept to launch, with travel as required and potential remote work options.

The position requires a Bachelor’s degree in science, engineering, or business and at least 5 years of PM experience in regulated medical device development. PMP is a plus.