Medical Device Project Manager

FRANCESCA MORICI

**** ******** ** **, *******, Georgia 30013 C: 914-***-**** (native New Yorker)

LinkedIn.com/in/FrancescaMorici Email: ****************@*****.***

Process Improvement l AI l Medical Device Compliance l Design Controls

Team & Senior Leadership Skills

Business Risk, Strategy, Mitigation

Strategic Planning & Change Mgmt

Quantified Team & Project Success

RIMSYS —> GUDID Submissions

Regulatory Intelligence, Standards

GS1, FDA 21 CFR, MDCG, EUMDR

QNCs, CAPAs, Risk, and Root Cause

Creative Direction, Brand, Design

MS Project, Excel, PPT, SharePoint

Master Control, Wrike, Smartsheet

Adobe CS, EtQ, RIMSYS, SAP, PIM

PROFESSIONAL EXPERIENCE

Avanos Medical 5405 Windward Pkwy, Alpharetta, GA (Remote) 9/2024 - current

Senior Program Manager – Regulatory Affairs – Medical Device Global Labeling

Regulatory Affairs Systems & Strategic Operations. GUDID M2M Submissions, via RIMSYS.

GTIN/UDI/BUDI formatting; GS1 Standards; Regulatory Frameworks - FDA, EU, ANVISA, TGA, NMPA and ROW.

Author of WIs, JAs, PRs/SOPs for RA Labeling, UDI, GTIN Allocation, M2M submissions, GUDID and EUDAMED.

AI: ChatGPT 5.0 + CoPilot to increase efficiencies, build Regulatory strategies, and grow business.

Proactive involvement on Change Control Board, Impact Analysis, Labeling Assessments, RA Compliance Reviews.

Portfolio management - Global Labeling, gap analysis, full Substantiation, Remediation planning, and execution.

Cross-functional collaboration with Quality, Packaging, Clinical, R&D, Commercial RA, Marketing and Supply Chain.

Acquisition Management, multi-country registrations, distributor agreements, and global submission requirements.

Proactively lead teams to find and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution.

Owens & Minor Kennesaw, GA (Remote) - Contracted by G-squared. 2/2024 – 8/2024

Consultant & Senior Project Manager – Medical Device Manufacturing & Global Compliance

Business Mergers & Acquisitions – BRM, business and financial analysis, including Best, Likely, and Worst-Case scenarios and projections to analyze potential outcomes for high-impact projects serving various lines of business.

Managed cross-functional teams and timelines: R&D, Regulatory Activities, Sustaining Engineering and NPD.

Lead large-scale manufacturing facility projects (upgrades, modifications, expansions, and transfers) from concept through commissioning and operational ramp-down/ramp-up.

Managed capital projects involving equipment breakdown, installation, qualification, and production start-up in a high-tech medical device manufacturing environment.

Bausch & Lomb Surgical St. Louis, Missouri (Remote) – Contracted by Kelly Services. 9/2022 – 5/2023

Consultant & Senior Project Manager – Global Compliance (Ocular Surgical Equipment and Devices)

FDA and MDR compliance. Implementation of medical device distribution in the US, EU, UK, EMEA, & ROW.

Change control, product risk and gap assessments, Supply Chain constraint management.

Software/Hardware development for Surgical Machines: change plans, revs, approvals of configuration specs, software V&V, software build, pilot/load codes on test servers, EMC testing, verification protocol execution.

Governed R&D timelines for stability, bio comp, sterilization validations, and other testing requirements.

Managed information updates and uploads of tech files and completion of DHFEs.

Managed audits, responded to queries. Provided oversight to obtain final approvals.

Beckon Dickinson & Company 8195 Industrial Blvd., Covington, GA 1/2021 - 8/2022

RA Labeling/MDR Senior Project Manager – (Urology & Critical Care – Acute, Endo, & Home Care products)

Managed design controls, remediation, and implementation of medical devices, kits, packs, and combo devices.

Managed cross-functional resources: RA, R&D, Clinical, Marketing, and vendors. Duration + dependencies.

Product life cycle management, new product requirements, scope development, and planning.

Responsible for successful completion of Labeling technical design reviews, status updates, and phase gate reviews.

Global Regulatory Labeling: conducted MDR gap analysis, management of redlines, updates to IFUs, PICs, PILs, DWGs, Labeling, UDI/PI & packaging. Accountable for updates to UDI/GTINs and GUDID.

Clinical management of Intended Use, Contraindications, Warnings, Precautions, Adverse Reactions/Side Effects, etc.

Attribute updates - DPM, Reprocessing, Storage/Handling, UDI Layers/Pkg, Mfg. Sites, CE Marking, Trade Compliance.

Rebranding of products. Worked closely with Marketing and Design on rebranding.

PEGA Power-User and Process Owner. Authored SOP for PEGA, the e-documentation system for BD’s website.

Heineken USA 360 Hamilton Ave., White Plains, NY - Contacted by ASL Global. 3/2020 – 11/2020

Portfolio & Project Manager – Global Brands

Strategic implementation of NPD goals across Heineken brands. Development of branded merchandise and experiences; focus on getting consumer-centric solutions to market.

Managed day-to-day Operations of product strategy, product definition, execution of product innovation, contract manufacturing, supply chain,, Marketing, Risk Management, and Budget Management.

Directly managed creative and branding teams and the lifecycle of branded promotional merchandise and signage.

JJD - Johnson & Johnson Design Agency 601 W 26th Street, New York, NY 10/2019 - 3/2020

Sr. Global Project & Portfolio Manager – Label Design of CPG, Consumer Brands

Managed and delivered iconic branding, label designs, and experiences to J&J Consumer Brands, some of which include Listerine, Band-Aid, Aveeno, Neosporin, Johnson’s Baby Oil, and Stayfree.

Governed design, brand, structural engineering, labeling, and packaging engineering, ensuring flawless development.

Managed consumer product label design projects, concept phase to production.

Responsible for final AW file reviews, reference materials, label design, packaging specs, and RA legal requirements.

TIFFANY & Co. 143 Sparks Ave., Pelham, NY 2/2019 - 9/2019

Quality Manager - Gemological Lab – Diamond Division

Ensured QA, V&V, size and accuracy of assets, NTQ/RTV stones according to established CODC guidelines.

BENCHMARK EDUCATION 145 Huguenot Street, New Rochelle, NY 1/2018 - 12/2018

Senior Content Project Manager, New Product Development

Scrum Master. Managed publication team of 20+, providing senior leadership in various management roles, including Graphic Designers, Photographers, Copy Writers, Editors, IT Engineers, and contract manufacturers/vendors.

Managed the full life cycle of publications, textbooks, teacher guides, resource systems, and ancillary materials.

Responsible for final proofing of content/copy, artwork, Pantones, design/layout, and production for a large series of over 600 ‘Leveled-Learning’ student books, print and digital versions.

PRIORITY GRAPHIX CORP 1171 Madison Ave., Paterson, NJ

Creative Director, New Project Development (360 Advertising/ Marketing Agency) 9/2010 - 12/2017

Sr. Graphic Designer, Program Manager 5/2007 – 9/2010

Lead contributor towards the achievement of the company’s strategic, innovative, and operational goals + growth.

Strategic global sourcing - Structural molding, signage, print, embroidery, laser etch, cylindrical, pad, oversized, etc.

SME / go-to for design, layout, rebranding, strategic branding, innovation, themes, packages, and key relationships!

Artwork development, marketing campaigns, advertising and promotions, online stores, client communications.

EDUCATION & ACHIEVEMENTS

William Paterson University Wayne, NJ

BFA Graphic Design

(2D & 3D AutoCAD, Adobe Illustrator & Photoshop)

Concentrated Studies: Mechanical Engineering, Architectural Engineering, Communications, Marketing

Outstanding Achievement: Awarded A+ for Thesis II: Environmental Protection & Sustainability

Montclair State University Montclair, NJ

Concentrated Studies: Business, Behavioral Psychology, Sociology, Anthropology

CERTIFICATIONS

Excel Data Analysis

EU Regulatory Executive Management

European Medical Regulations (EUMDR) - 2017/745

ISO 13485:2016 Quality Management Systems for Medical Devices

Exercising Leadership: Foundational Principles, HarvardX, online.

MEMBERSHIPS / INDUSTRY AFFILIATIONS

RAPS

GMDN

AAMI

ISO Working Groups

MedTech Working Groups

GS1 Exchange & Working Groups

Johner Institute for Healthcare Quality & Safety

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