The following requirement is open with our client.
Title : Technical Project Manager – Medical Devices (Labeling & Regulatory)
Location : Irvine, CA~Raritan, NJ(Onsite)
Duration : 12+ Months
Rate : 40$ - 43$ /hr on W2
Relevant Experience (in Yrs.) :
Job Description:
We are seeking an experienced Technical Project Manager with strong expertise in medical device labeling and regulatory project execution.
The ideal candidate will drive cross-functional initiatives, ensure regulatory compliance, manage complex labeling changes, and lead continuous improvement efforts across global product portfolios.
Key Responsibilities
Project & Portfolio Management
Develop, communicate, and execute integrated project plans (charter, scope, schedule, milestones, budget, risks, and issues).
Monitor project progress and performance; proactively resolve issues, mitigate risks, and minimize delays.
Manage multiple parallel projects across product lines and geographies.
Estimate costs, resources, and timelines for impacted products, labels, IFUs, change requests, and change notifications.
Serve as the primary point of contact for:
Technical Leaders (technical issues)
Functional Managers (resource planning)
Executive Sponsors (project status & escalations)
Labeling & Regulatory Execution
Lead labeling regulatory projects and Windchill CR/CN processes.
Review labeling updates for content accuracy and regulatory alignment.
Ensure compliance with applicable corporate, divisional, and regulatory standards (Medical Devices/Pharma).
Manage complex label content across diverse medical device portfolios.
Drive timely closure of labeling-related activities.
Cross-Functional Leadership
Align resources and stakeholders across:
Coordinate with external vendors (print vendors, contract manufacturers, EMs, NPI teams).
Conduct project meetings and provide regular executive-level status reports.
Mentor and guide cross-functional teams.
Process Optimization & Continuous Improvement
Apply Six Sigma and Value Stream Mapping to optimize processes.
Lead continuous improvement initiatives using Agile or hybrid methodologies.
Analyze tools and workflows; recommend and implement efficiency improvements.
Drive structured problem-solving for complex project scenarios.
Required Technical Skills
Strong expertise in Project & Portfolio Management methodologies (road mapping, risk management, financial tracking).
Deep knowledge of Medical Device functional areas (Labeling, Regulatory, Manufacturing).
Experience with:
MRP systems
Production Planning (forecasting, capacity planning, scheduling)
Change management systems (e.g., Windchill CR/CN)
Strong understanding of Regulatory Compliance standards (Medical Devices/Pharma).
Hands-on experience with project management tools (MS Project, JIRA, or similar).
Advanced knowledge of:
PMP or equivalent Project Management Certification preferred.
Essential Competencies
Strong leadership and mentoring skills.
Excellent communication (written & verbal) and interpersonal abilities.
Strong organizational and planning skills.
Ability to multitask and manage competing priorities effectively.
Strong analytical, decision-making, and situational judgment skills.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Ability to generate trackers, dashboards, and executive reports.
Preferred Experience
8+ years of experience in Medical Devices or regulated industries.
Proven experience in labeling regulatory project execution.
Experience managing global, cross-functional teams.
Exposure to QMS and Portfolio Management frameworks.
Must Have Skills
Thanks & regards,
Shireesha Thanniru
Technical Recruiter
ASCII Group, LLC Website:
38345 W 10 Mile Rd, Suite 365, Farmington, MI 48335, US
Office: Email:
Never miss an opportunity! Create an alert based on the job you applied for.
