Remote IVD Product Development Manager

Meridian Bioscience, Inc.; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Meridian Bioscience, Inc. is seeking a Project Manager to lead cross-functional new product development projects for IVD assays and diagnostic instrument systems in an FDA-regulated environment. The role covers planning and execution from concept to launch, with emphasis on design control, schedule, risk, resources, budget and clear decision-making.

Remote flexibility with travel as required. The successful candidate will partner with R&D, Regulatory Affairs, Quality, Clinical Affairs,

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.
• Preferred: Experience with in vitro diagnostic (IVD) products and diagnostic instrument development.
• Preferred: Project management qualification (PMP) or equivalent.
• Preferred: Experience with Quality Management Systems compliant with FDA 21 CFR Part 820 and applicable medical device regulations.
• Travel: 20% travel.

Responsibilities

• Define project scope, goals and deliverables and manage projects.
• Develop accurate, achievable project plans and timelines and communicate them to team members and leadership.
• Drive team ownership and commit to project plans; recommend changes to meet outputs.
• Track and communicate project performance and milestones.
• Ensure on-time completion of tasks as required by the project and procedures.
• Facilitate cross-functional project team meetings.
• Other duties as assigned.

Skills

Project management

Cross-functional

FDA-regulated

Design control

Risk management

PMP

Communication skills

Time management

Diagnostics knowledge

Education

Bachelor's degree

Advanced degree

Job description

Meridian Bioscience, Inc. is seeking a Project Manager to lead cross-functional new product development projects for IVD assays and diagnostic instrument systems in an FDA-regulated environment. The role covers planning and execution from concept to launch, with emphasis on design control, schedule, risk, resources, budget and clear decision-making.

Remote flexibility with travel as required. The successful candidate will partner with R&D, Regulatory Affairs, Quality, Clinical Affairs,