Project Manager – IVDR Technical Files & Label Cutover

Key Responsibilities

• 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.
• Cook up 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.

Key Qualifications

• 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.
• 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.
• Achieve project documentation maintenance in accordance with quality and regulatory requirements.
• Aid teams in identifying and mitigating risks that could impact regulatory timelines or market continuity.

Benefits

• Health Insurance: Medical, dental, and vision coverage.
• Retirement Plans: Participation in a company-sponsored retirement savings plan.
• Legal Service Plans: Access to attorneys for legal advice and representation.