Project Manager

About FiunEx: FiunEx is a highly specialized profit improvement operation consulting and Engineering service firm,which has a proven track record in flawless execution of projects in over 25 countries. We have developed a niche in Life Sciences sector driving majority of our revenues.

Through our unique engagement model and its success, we have experienced extremely tremendous growth in a short duration. We now have presence in US, Ireland, India and Thailand. For more details about the company, visit our website at www.fiunex.com.

Job Description

Project Manager – Labelling Compliance & Remediation

Position Overview

We are seeking an experienced Project Manager to lead and coordinate a cross-functional Art/Label Remediation and G51 Labelling Compliance initiative. The role will be responsible for planning, coordinating, tracking, and driving project execution across multiple workstreams to ensure timely completion of labelling updates in support of 3PL phased transition timelines.

The ideal candidate will be highly organized, detail-oriented, and comfortable managing multiple stakeholders, dependencies, risks, and competing priorities. Experience working in a regulated environment, particularly within the medical device industry, is preferred.

Key Responsibilities:

• Lead and coordinate the end-to-end execution of the Art/Label Remediation and G51 Labelling Compliance project.
• Develop and maintain detailed project plans, timelines, milestones, dependencies, and action trackers.
• Coordinate activities across QA, R&D, Sourcing, Operations, suppliers, and other relevant stakeholders.
• Track deliverables and ensure labelling updates are completed in accordance with project timelines and 3PL phased transition requirements.
• Facilitate regular project meetings, prepare agendas, document decisions, and drive timely closure of action items.
• Provide clear and accurate weekly project status updates to relevant stakeholders and leadership.
• Identify, assess, and proactively manage project risks, issues, dependencies, and potential delays.
• Escalate critical risks and issues in a timely manner and coordinate appropriate mitigation and resolution plans.
• Coordinate change control activities and ensure project changes are appropriately documented, assessed, and communicated.
• Consolidate and summarize large volumes of project information into clear, concise management updates.
• Maintain accurate project documentation, trackers, timelines, and status reports.
• Monitor cross-functional dependencies and proactively follow up with stakeholders to ensure commitments are met.
• Support alignment between regulatory/compliance requirements and operational project execution.
• Identify potential gaps in execution and drive corrective actions to maintain project milestones.
• Support project governance and ensure appropriate visibility of progress, risks, decisions, and outstanding actions.

Required Qualifications & Experience:

• Bachelor's degree in Business Administration, Project Management, Engineering, Life Sciences, or a related field.
• 3–7 years of project management experience, preferably in a regulated industry or complex cross-functional environment.
• Proven experience managing multiple workstreams, timelines, stakeholders, and project dependencies.
• Strong experience with project planning, tracking, status reporting, risk management, and meeting facilitation.
• Demonstrated ability to coordinate and influence cross-functional teams without direct reporting authority.
• Strong organizational and follow-up skills with excellent attention to detail.
• Ability to analyse and summarize large amounts of information and communicate key messages clearly.

Technical Skills:

• Smartsheet – preferred
• Microsoft Project
• Advanced working knowledge of Microsoft Excel
• Basic knowledge of Salesforce
• Familiarity with ComplianceQuest or similar quality/compliance management systems
• Strong capability in project tracking, reporting, data consolidation, and presentation of project information.

Preferred Domain Knowledge:

• Basic understanding of medical device labelling and labelling-related processes.
• Familiarity with UDI (Unique Device Identification) requirements.
• Basic understanding of change control processes within a regulated environment.
• Familiarity with GS1 standards and G51 labelling requirements.
• Understanding of regulatory-driven project timelines and compliance deliverables.
• Experience working with Quality, Regulatory, R&D, Operations, Sourcing, or Supply Chain teams is advantageous.

Key Competencies:

• Project planning and execution
• Stakeholder management
• Cross-functional collaboration
• Risk and issue management
• Change management
• Problem solving and decision making
• Strong attention to detail
• Data analysis and information synthesis
• Meeting facilitation
• Accountability and follow-through
• Clear written and verbal communication
• Ability to work effectively in a fast-paced, deadline-driven environment

Key Performance Indicators:

Success in this role will be measured through:

• Adherence to project milestones and timelines
• On-time completion of labelling remediation deliverables
• Accuracy and timeliness of project status reporting
• Effective identification, escalation, and resolution of project risks and issues
• Timely closure of action items and cross-functional dependencies
• Effective coordination of project changes and change control activities
• Successful execution of labelling updates in support of 3PL transition timelines
• Stakeholder alignment and effective cross-functional communication

Key Stakeholder Interfaces

The role will work closely with:

• Quality Assurance (QA)
• Research & Development (R&D)
• Sourcing / Procurement
• Operations
• Supply Chain / 3PL partners
• Suppliers / External Partners
• Regulatory / Compliance stakeholders
• Project and business leadership

Reporting & Communication

• Provide weekly project status updates covering progress, milestones, risks, issues, dependencies, and key actions.
• Maintain transparent and timely communication with project stakeholders.
• Ensure leadership has appropriate visibility of project health, critical risks, and required decisions.

Ideal Candidate Profile:

The ideal candidate is a hands-on Project Manager who can bring structure to complex, cross-functional initiatives, proactively chase dependencies, identify risks before they become issues, and translate detailed project information into clear business updates.

Experience in medical device labelling, UDI, GS1 standards, or regulated change control will be an advantage, but strong project management capability and the ability to operate effectively across multiple functions are critical to success.