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Senior Project Manager

Meridian Bioscience Corporation

Cincinnati, OHJobSeen todaySeen in employer's feed today

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At a glance

Compensation
No compensation found
Location
Cincinnati, OH
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

The Senior Project Manager leads complex, cross-functional development projects for in vitro diagnostic assays and instrument systems in an FDA-regulated medical device environment. The role oversees planning and execution from concept through launch, including design control compliance, schedules, risks, resources, budgets, and decisions. It partners with internal functions and external development partners, and may be based in Cincinnati or performed remotely, with travel as required.

Skills & qualifications

RequiredNice to have

Skills

Project ManagementCross-Functional LeadershipProduct DevelopmentFDA-Regulated IVD DevelopmentProject PlanningRisk ManagementMedical Device Design ControlsDesign ReviewsVerification and ValidationRegulatory Submissions

Qualifications

Bachelor's in Science, Engineering, Business Administration or Related FieldAdvanced Degree7+ Years Project Management ExperienceFDA Clearance or Approval and U.S. Commercial Launch

Full job description

Senior Project Manager Job Locations US-Remote Company Meridian Bioscience, Inc. Department Research and Development # of Openings 1 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 a

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