Project Manager – IVDR Technical Files & Label Cutover
Pay Range: $58 to $60/Hour on W2
Clinical Diagnostics Division – Niche Diagnostics
This position is part of the Clinical Diagnostics Division (CDD), which provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the IVD industry for over 40 years. CDD delivers products for drugs of abuse testing, therapeutic drug monitoring, quality control, sepsis diagnosis, prenatal screening, advanced laboratory instrumentation, and high-throughput laboratory automation equipment for use in a variety of laboratory settings.
Client Impactful Work
The Project Manager will support the planning, coordination, and execution of IVDR Technical File assembly, DOC sign-off and labeling cutover projects across the Clinical Diagnostics portfolio. This role partners closely with Regulatory Affairs, Quality, R&D, Operations, Supply Chain, Labeling, and Commercial teams to ensure project milestones are achieved and regulatory commitments are met.
The successful candidate will be highly organized, collaborative, and detail-oriented, with experience managing cross-functional projects in a regulated environment.
Key Responsibilities
Project Management
* Manage assigned IVDR Technical File and labeling projects from initiation through implementation.
* Develop and maintain project plans, timelines, action logs, risk registers, and status reports.
* Coordinate cross-functional teams to ensure project deliverables are completed on schedule.
* Track project milestones, dependencies, risks, and issues, escalating concerns as appropriate.
* Facilitate project meetings and ensure timely follow-up on action items.
* Support change management activities associated with product labeling updates and regulatory submissions.
Cross-Functional Collaboration
* Partner with Regulatory Affairs, Quality Assurance, Operations, Supply Chain, Manufacturing, Marketing, and Product Management teams.
* Drive alignment on project timelines, deliverables, and implementation plans.
* Support communication of project status, risks, and key decisions to stakeholders and leadership.
* Build strong working relationships across functions to support successful execution.
IVDR Technical Files & Label Cutover Support
* Coordinate activities related to IVDR technical documentation updates and remediation efforts.
* Support implementation of labeling changes required for IVDR compliance and product transitions.
* Track readiness activities, inventory considerations, and cutover milestones.
* Ensure project documentation is maintained in accordance with quality and regulatory requirements.
* Assist teams in identifying and mitigating risks that could impact regulatory timelines or market continuity.
Education:
Bachelor’s degree in Life Sciences, Engineering, Business, Regulatory Affairs, or a related field.
Experience:
* 3–5 years of project management, project coordination, regulatory, quality, or operations experience within the medical device, diagnostics, healthcare, or other regulated industry.
* Experience working on cross-functional projects with multiple stakeholders.
* Exposure to regulatory compliance initiatives, product lifecycle management, labeling changes, or technical documentation projects preferred.
* Experience supporting IVDR or other regulated product environments is highly desirable.
Preferred Qualifications
Understanding of medical device or diagnostic regulatory requirements, particularly IVDR, is a plus.
Knowledge, Skills & Abilities
* Strong organizational and project coordination skills.
* Ability to manage multiple priorities in a fast-paced environment.
* Excellent written and verbal communication skills.
* Effective facilitator of cross-functional meetings and discussions.
* Strong attention to detail and follow-through.
* Proficiency with Smartsheet, Excel, PowerPoint, and collaboration tools.
* Ability to identify risks and drive timely resolution with stakeholder support.
* Collaborative team player with a proactive, solution-oriented mindset.
* Comfortable working independently while escalating issues appropriately.