Project Manager Management

Professional Summary

Strategic and detail-driven project leader with 20+ years of experience in the medical device and pharmaceutical industries. Proven success in leading global cross-functional teams through product development, UDI compliance, packaging and labeling, and regulatory integration initiatives. Adept in managing complex, multi-country product launches and lifecycle management across therapeutic areas. Recognized for optimizing operations, ensuring regulatory compliance, and driving process innovation in highly regulated environments.

Education & Certifications

Bachelor’s Degree Kutztown University 1999

Project Management Certificate – Internal Company Training Cert, 2020

UDI & Regulatory Compliance Training – Internal Company Training, 2015

Core Competencies:

Global Program & Project Management (Agile & Waterfall)

UDI Compliance & Global Data Integration (GDSN, GS1, HIBC)

Regulatory Affairs Support (FDA, EU MDR, ROW)

Labeling Lifecycle Management (PLM, SAP, Adobe)

Cross-functional Team Leadership

Risk & Change Management (RAID Logs, FMEA)

Vendor Management & Quality Compliance (QSR, ISO)

Budget & Resource Planning

Professional Experience

Integra LifeSciences – Plainsboro, NJ

Project Manager (Global Projects – Labeling & Regulatory)

Mar 2024 – Present

Leading cross-functional programs across labeling, packaging, and regulatory for new product development and lifecycle initiatives.

Driving stakeholder alignment on process changes to reduce risk and ensure continuity of supply during product transitions.

Facilitating coordination between regulatory, R&D, quality, supply chain, and global sites for strategic initiatives.

Operations Manager – UDI Global Initiative

Oct 2014 – Mar 2024

SME for FDA UDI Final Rule implementation; led labeling compliance for GS1/GTIN conversion across all manufacturing and distribution sites.

Directed global assignment and registration of GTINs to certified data pool providers and ensured GDSN synchronization.

Oversaw integration of Direct Part Marking (DPM) initiatives across site operations.

Developed and maintained procedures for UDI labeling requirements in collaboration with Regulatory Affairs.

Enabled global traceability and barcode readiness with transition from HIBC to GS1 standards.

Bristol Myers Squibb – Princeton, NJ

Project Manager – Advertising & Marketing Services

Mar 2014 – Oct 2014

Managed digital and print marketing assets for Cardiovascular product portfolio, ensuring regulatory and promotional compliance.

Partnered with brand teams and external agencies to meet aggressive launch timelines and track multi-channel deliverables.

ConvaTec (formerly a division of BMS)

Global Packaging & Labeling Project Manager – Wound Therapeutics & Skin Care

Apr 2013 – Oct 2013

Led global cross-functional teams on packaging and labeling programs supporting product launches and regulatory updates.

Drove commercialization readiness by aligning regulatory, legal, quality, and supply chain functions.

Implemented process improvements to streamline packaging workflows and ensure FDA and ISO compliance.

Packaging Art Compliance Leader

Jan 2007 – Apr 2013

Ensured GMP-compliant execution of all packaging artwork for global product lines.

Successfully transitioned from manual to electronic proofing, reducing cycle times by over 50%.

Managed CEDAR-based proof routing system; collaborated with vendors and cross-functional stakeholders.

Wyeth Pharmaceuticals (Pfizer) – Collegeville, PA

Proofreader – Global Labeling & Regulatory Artwork

Mar 2002 – Jan 2007

Performed critical reviews of regulatory labeling content in multiple languages across immediate container, unit carton, and shipping components.

Used TVS (Total Vision System) for visual inspection and compliance verification.

Supported quality teams by compiling metrics reports and participating in process standardization teams.

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