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 that 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 Senior Project Manager leads complex, 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, dependencies, and clear decision-making. The Senior applies deep project management experience to anticipate and resolve complex issues, align cross-functional stakeholders, and drive timely decisions and escalations with limited oversight. The Senior 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, deliverables, success criteria, and governance for complex product development projects

Develops and maintains accurate, achievable integrated project plans and timeline, including critical path, dependencies, resource needs, and key decision points; consistently communicates the plans and changes with team members and the leadership team
Drives team ownership and commitment to project plans; proactively identifies risks, issues, and tradeoffs and recommends changes needed to meet project objectives
Tracks, analyzes, and communicates project performance, including schedule, milestones, risks, resources, and budget, and provides clear status, forecasts, and escalations to leadership
Ensures on-time completion project deliverables in accordance with project commitments, design control requirements, and applicable company procedures
Leads and facilitates effective cross-functional project team, decision making, issue resolution, and alignment across functions and external partners
Other duties as assigned

Qualifications

Bachelor’s degree in science, engineering or business administration or related field required; advanced degree preferred.
At least 7 years of project management experience leading cross-functional product development projects, including significant experience managing complex, multi-functional projects from concept through launch.
Direct experience managing FDA-regulated vitro diagnostic (IVD) product development projects, with demonstrated responsibility for schedule, risk, resources, budget, and cross functional execution.
Proven track record of successfully leading IVD products through FDA clearance or approval and commercial launch in the U.S. market.
Strong working knowledge of medical device design control requirements and product development processes, including design planning, design reviews, risk management, verification and validation, transfer, regulatory submission, and launch readiness.
Demonstrated experience with IVD products, including assay and/or diagnostic instrument development.
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 advanced Project Management skills with proven record of practical project management experience preferably in the diagnostic field
Demonstrate successful leadership of product development projects with significant technical, regulatory, operational, and/or cross-functional complexity.
Must have strong capability to perform critical path analysis, dependency management, risk management, and scenario planning.
Excellent problem-solving and decision-support skills. Must be a self-starter, detail-oriented and able to prioritize competing demands, balance workloads and timelines and ability to work on multiple projects simultaneously
Must be able to work independently with limited oversight while influencing and collaborating with peers, functional leaders, senior stakeholders, and external partners 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, written and oral communication skills
Basic understanding of IVD product development, including assay and/or instrument development, engineering, verification and validation, regulatory, quality, clinical, manufacturing, transfer, and launch activities.

Travel: 20%

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*

#J-18808-Ljbffr

Meridian Bioscience International Limited jobs

Senior Project Manager

Senior Project Manager, IVD & Medical Devices — Remote

Never Miss a New Opportunity