Job Summary

The Onsite Labeling Project Manager will lead and manage eIFU (electronic Instructions for Use), labeling remediation, and packaging change projects across multiple BD product portfolios. This role is responsible for driving end-to-end project execution from initiation through commercial release while ensuring compliance with global regulatory requirements, design control processes, and labeling standards.

The Project Manager will serve as the primary point of coordination between Regulatory Affairs, Quality, Manufacturing, Supply Chain, Labeling Operations, Packaging Engineering, and external partners to ensure successful implementation of labeling and eIFU programs across global markets.

Location: Covington, Georgia (Onsite)

Key Responsibilities

Project Leadership

• Lead end-to-end eIFU and labeling remediation projects from project initiation through commercial release.
• Develop and maintain integrated project plans, schedules, resource plans, risk registers, and project dashboards.
• Establish project governance structures, communication plans, stakeholder engagement strategies, and executive reporting mechanisms.
• Drive project execution across multiple product families, manufacturing sites, and global markets.
• Monitor project milestones, budgets, resource utilization, risks, and overall project performance.
• Facilitate project review meetings and provide regular status updates to BD leadership.

eIFU Program Management

• Manage transition programs from paper-based IFUs to electronic IFU platforms.
• Coordinate country-specific eIFU eligibility assessments and implementation strategies.
• Oversee eIFU publication, validation, metadata management, and lifecycle maintenance activities.
• Ensure compliance with BD eIFU procedures, global regulations, and internal quality requirements.
• Coordinate implementation activities across Regulatory, Quality, Manufacturing, and Commercial teams.

Labeling & Design Control Management

• Lead labeling gap assessments, impact assessments, and scope definition activities.
• Coordinate development, review, and approval of:
• Product Change Histories (PCHs)
• PEGA Requests
• Label Change Requests (LCRs)
• Engineering Change Requests (CRs)
• Label Specifications
• Infocards
• AFC Releases
• Redline Reviews
• Manage document workflows and approval cycles across cross-functional teams.
• Ensure compliance with BD design control processes, change management procedures, and labeling standards.

Regulatory & Quality Coordination

• Partner with Regulatory Affairs to evaluate eIFU eligibility and global regulatory requirements.
• Coordinate product impact assessments and regulatory documentation activities.
• Support audits, inspections, compliance reviews, and quality system requirements.
• Ensure project deliverables meet applicable regulatory, quality, and business expectations.
• Drive closure of project risks, issues, and regulatory commitments.

Manufacturing & Supply Chain Readiness

• Coordinate manufacturing readiness activities, including:
• Digital Proof Reviews
• Packaging Component Updates
• Supplier Coordination
• PPAP Activities
• Bill of Material (BOM) Updates
• SKU Implementations
• Manage implementation schedules with manufacturing facilities and quality organizations.
• Identify and mitigate risks associated with component availability, supplier readiness, and implementation timelines.
• Support launch readiness and commercialization activities.

Resource & Stakeholder Management

• Lead cross-functional project teams consisting of:
• Labeling Specialists
• Packaging Engineers
• Regulatory Affairs Representatives
• Quality Engineers
• Manufacturing Representatives
• Document Control Specialists
• External Vendors
• Facilitate project meetings, governance reviews, and executive decision-making forums.
• Coordinate team workload planning and resource allocation across multiple programs.
• Build strong relationships with BD stakeholders and ensure alignment on project priorities and deliverables.

Skill Requirements

• Strong Project Management experience in regulated industries.
• Experience managing labeling, packaging, eIFU, remediation, or product lifecycle projects.
• Excellent stakeholder management and cross-functional leadership capabilities.
• Strong understanding of design control, change control, and document management processes.
• Experience with project planning, scheduling, risk management, and executive reporting.
• Strong communication, presentation, and organizational skills.
• Ability to manage multiple complex projects in a fast-paced environment.

Preferred Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 10+ years of experience in project management, preferably within Medical Devices, Pharmaceutical, or other regulated industries.
• Experience working with global regulatory requirements related to product labeling and eIFU implementation.
• Knowledge of FDA Quality System Regulations, ISO 13485, MDR, and medical device labeling requirements.
• PMP certification preferred.

Other Requirements

Tools & Systems

• Microsoft Project / OnePlan
• MasterControl
• PEGA
• Microsoft Office Suite
• SharePoint
• Power BI
• Document Management Systems
• eIFU Management Platforms

Preferred Experience

• Medical Device Labeling Remediation Programs
• eIFU Implementation Projects
• Global Product Change Management
• Regulatory Compliance Programs
• Packaging and Labeling Operations

Manufacturing Transfer and Commercialization Activities