Head of Project Management (Remote)

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 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
Qualifications Bachelor’s degree in science, engineering or business administration or related field required; 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
Experience working within Quality Management Systems compliant with FDA 21 CFR Part 820 and applicable medical device regulations.
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 be a self-starter, detail oriented and able to prioritize and balance workloads and timelines and ability to work on multiple projects simultaneously
20% travel

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