Project Manager, In Vitro Diagnostics Class III Device

Project Manager, In Vitro Diagnostics Class III Device

Overview

We are seeking an experienced Project Manager with a strong background in In Vitro Diagnostics (IVD) and regulatory submissions, particularly supporting Class III medical devices. This role will lead cross-functional programs from development through submission and launch, ensuring compliance with global regulatory requirements and internal quality standards.

Key Responsibilities

• Lead end-to-end project management for IVD product development and regulatory submissions, including Class III devices
• Drive integrated program planning, aligning timelines, resources, and cross-functional deliverables
• Manage and maintain Design Traceability Matrix (DTM) ensuring linkage between:
• Design Inputs
• Design Outputs
• Verification & Validation (V&V) activities
• Oversee development and maintenance of the Risk Management File in accordance with ISO 14971
• Coordinate and support preparation of regulatory submissions (e.g., PMA, 510(k), IVDR technical documentation)
• Facilitate cross-functional collaboration across R&D, Regulatory Affairs, Quality, Clinical, and Manufacturing teams
• Maintain and manage decision logs, ensuring clear documentation of key project decisions, risks, and trade-offs
• Identify risks, develop mitigation strategies, and ensure alignment with project and regulatory expectations
• Track project progress, milestones, and deliverables; provide regular updates to stakeholders and leadership

Required Qualifications

• Bachelor’s degree in a relevant field (Engineering, Life Sciences, or related)
• 5+ years of project management experience in medical devices or IVD
• Proven experience supporting or leading IVD regulatory submissions
• Experience with Class III device development and launch (PMA preferred)
• Strong understanding of:
• Design Controls (21 CFR Part 820 / ISO 13485)
• Risk Management (ISO 14971)
• IVD regulatory pathways (FDA, IVDR)
• Hands-on experience managing:
• Design Traceability Matrices
• Risk Management Files
• Integrated project plans
• Excellent communication and stakeholder management skills

Preferred Qualifications

• PMP or equivalent project management certification
• Experience with IVDR (EU) submissions and CE marking
• Familiarity with clinical and analytical validation processes for IVDs
• Experience in regulated environments with cross-functional program leadership