Project Manager, In Vitro Diagnostics Class III Device

Project Manager, In Vitro Diagnostics Class III Device at Medasource Project Manager, In Vitro Diagnostics Class III Device at Medasource in Berkeley, Illinois Posted in 2 days ago.

Type:

full-time

Job Description:

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