Remote Project Manager, FDA-Regulated IVD & NPD

Meridian Bioscience International Limited; Cincinnati (OH); Hybride; USD 110 000 - 140 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Project management

Cross-functional leadership

FDA-regulated

Design controls

Risk management

IVD products experience

PMP certified

Communication skills

Travel readiness

Formation

Bachelor's degree in science/engineering/business

Advanced degree preferred

Description du poste

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals who help drive our vision.Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting-edge solutions to tough problems.

Job Summary

The Project Manager leads cross-functional new product development projects for in vitro diagnostic (IVD) assays and diagnostic instrument systems in an FDA-regulated medical device environment. This role is accountable for project planning and execution from concept through launch, with emphasis on design control compliance, schedule, risk, resources, budget, and clear decision-making. The Project Manager partners with R&D, Regulatory Affairs, Quality, Clinical Affairs, Operations, Marketing, and external development partners to achieve business and product objectives. The position may be based locally in Cincinnati or performed remotely, with travel as required to support project teams and key milestones.

Key Duties

• Partner with R&D, Operations, Regulatory Affairs, Quality, Clinical Affairs, Finance, and Marketing and others to define project scope, goals and deliverables as well as successfully manage projects • Develops accurate, achievable project plans and timeline, consistently communicating the plans with team members and the leadership team

• Drives team ownership and commitment to project plans and recommends changes when necessary to meet project outputs • Tracks and communicates project performance, specifically to analyze successful completion of short- and long-term goals • Ensures on-time completion of tasks as required by the project and/or company procedures • Facilitates cross-functional project team meetings • Other duties as assigned

Qualifications

• Bachelor’s degree in science, engineering or business administration or related field required; advanced degree preferred. • At least 5 years of project management experience leading cross-functional product development projects. • Direct experience managing FDA-regulated medical device product development projects. • Working knowledge of medical device design control requirements and product development processes, including design planning, design reviews, risk • Preferred: Experience with in vitro diagnostic (IVD) products, including assay and/or diagnostic instrument development. • Preferred: Experience working within Quality Management Systems compliant with FDA 21 CFR Part 820 and applicable medical device regulations. • Preferred: Project management qualification (PMP) or equivalent.

• Demonstrated Project Management skills with proven record of practical project management experience preferably in the diagnostic or related biotechnical field • Demonstrate successful management of product(s) from concept to launch • Must have the ability to perform critical path identification • Excellent problem-solving skills. Must be a self-starter, detail oriented and able to prioritize and balance workloads and timelines and ability to work on multiple projects simultaneously • Must be able to work independently as well as collaboratively with peers and colleagues in a cross functional setting • Must be well organized and have the ability to meet strict deadlines and perform under pressure in a fast-paced work environment • Excellent interpersonal, organizational and written and oral communication skills

• Basic understanding of device development, engineering, and manufacturing activities is a plus

• 20% travel