Jennagloria (Jenna) Pacheco, Pmp Email & Phone Number

San Jose, California, United States

Manage Healthcare Professionals (HCPs) & Organizations (HCOs) Contracts/Partnerships (Jan 2023 - Present)• Interact and assist cross-functional teams and corporate functions with management of activities that include setting up and managing legal contracts with HCPs and HCOs in compliance with corporate policies.• Review of intellectual property, global privacy, and ethics & compliance laws and guidelines.• Draft and organize business correspondence, maintain and archive legal documents.• Interact and become familiar with the electronic database “Interactions Hub” to manage HCP and HCO engagements with BD.• Research of foreign documents for compliance and privacy.IVDR Transition (Aug 2021 - Dec 2022)• Project Manager for IVDR transition of Class A & C projects.• Work with cross-functional leads to execute both high-level and detailed project plans that impact multiple global locations and functions.• Timeline driven to ensure all milestones and deliverables are completed in expected timeframe.• Direct communication with key stakeholders and support advising on handle of associate risks.

New Jersey, United States

• Project Manager for MDR/IVDR transition impacting 2 manufacturing locations (Client: Thermo Fisher Scientific, Dec 2020 - Jun 2021)• Support ViSU implementation projects

Greater New York City Area

• Fun Factory Sensory Gym (June 2023 - Present)• BD Biosciecnes (Aug 2021 - Present)• Makrocare (Dec 2020 - Present)• Bausch Health (Feb 2019 - Dec 2020)

Bridgewater, Nj

• Oversee MDD gaps assessments which includes managing output timelines, develop recommended solutions for gap(s) remediation, create and present summary reports to upper management, and complete assessments for Surgical Portfolio.• Support MDR transition team in assessing existing labeling for any gaps and creation of pilot for MDR Technical File in existing controlled document system. • Support overseeing implementation for regulatory related CAPAs including those impacting external standards and labeling. Responsible for expected timeline, communicating with Subject Matter Experts, and ensuring corrective active be executed by project due date.• Review all Technical Files changes/updated completed by third party vendor including initial creation, annual reviews, and Significant Change Notifications.• Review, write, and update regulatory-related standard operating procedures/work instructions as required, which include procedures related to technical file writing, external standards, electronic file storage, and other regulatory roles & responsibilities.• Regulatory liaison for MDD Technical File storage in company-controlled document system, Documentum. Manage the transfer and storage of 40+ medical device technical files in system. Department point of contact for any user issues and queries related to system.

Mahwah, Nj

• Control Reconstructive Division regulatory product hold related requests, including release of product for global market orders. • Manage product donation requests for worldwide missions from a regulatory approval standpoint.• Oversee product obsolesce and activation in addition to working directly with Product Life Cycle Management (PLCM) team for approving and implementing product changes.• Implement and manage regulatory procedure changes comprising of creating change requests (ECR), change notifications (ECN), change activities (CA), and leading review of all changes with process owners and approvers.• BSI Audit Finding CAPA Project – Regulatory lead for remediation project impacting approximately 9,000 CE Class IIa & IIb parts, including obsolesces for over 4,500 parts. • Approver & reviewer of Instruction for Use changes. Project liaison between legal and labeling teams.

Carteret, Nj

• Stepped away from career to develop own business. • In charge of all back-end business operations which included tasks such as hiring/firing staff, creating employee handbooks, new hire training, vendor & staff meetings, approving marketing material, inventory tracking/ordering, creating budgets, and managing accounting.

Plainsboro, Nj

• Assisted in the management of implementation efforts from an international regulatory perspective by ensuring continuous communication and calculating/tracking project timelines including estimated registration approval dates, required product build, and management of product transition from current to new manufacturing facility for the entire project team. • Oversaw expected timelines and reviewed factory regulatory teams’ US & CE regulatory filings for submission to Notified Bodies (PMA & DD Supplements, TF Updates) for new manufacturer approval.• Liaison between franchise and International Distributors to satisfy individual country product registration requirements through efficient and effective process, time, and priority management.

Somerville, Nj

• Supervised Regulatory Coordinator & Associate in preparing documents required for International submissions to re-register product, obtain necessary government certifications (i.e. CFG/CFS), appropriate government legalization, as well as mail & track delivery of legal documents.• Assisted in the management of implementation efforts from a regulatory perspective for entire project by ensuring continuous communication, relevant product approvals, calculating/tracking project timelines including estimated registration approval dates, required product build, and management of product transition from current to new manufacturing facility.• Submitted PMA & PMA Supplement for change in manufacturer of Finish Good & product formulation. • Evaluated products transferring (total of 3,000 parts) to new manufacturing facility to determine whether or not the changes in scope require a regulatory submissions. • Prepared Technical Files and Significant Change Supplements for all CE Risk Class I & IIa medical devices and completed submission for audit to Notified Body, BSi. • Regulatory contact with Operations Lead, Quality Engineer, and other team members in regards to all process, validation testing, and product changes related to CE Risk Class I, IIa, and IIb devices.

Somerville, Nj

• In charge of providing Regulatory data for ADAPTIV Product Lifecycle Management System (PLM).• Collected regulatory attribute data per product code for US and EU regulations. Regulatory attributes included but not limited to: FDA Product Code, Medical Device Listing Number, 510(k) #, Premarket Approval Number, National Drug Application, Regulatory Risk Class, and GMDN Code.• Created test scripts for each business unit (Ethicon Product, J&J Wound Management, and Ethicon Women’s Health & Urology) to include all marketed product codes and associated regulatory attributes, totaling implementation of regulatory data for over 30,000 parts.

Somerville, Nj

• Prepared and submitted New Product Applications, Design Examination Certificate Renewals, and Significant Change Supplements for various product changes including design, process, & package.• Reviewed and updated all Design Dossiers and Technical Files for Ethicon Inc. and Johnson & Johnson International medical devices (over 100 product lines) to demonstrate compliance to EC Directive 93/42/EEC as amended by the Medical Device Directive 2007/47/EC.• Audit preparation readiness for an on-site visit by the Notified Body, BSi.

Florham Park, Nj

SAP Implementation (Client: Bristol Myers Squibb)• Created training documentation for 14 different Informatics Workshops.Quality Training & Development (Client: Verizon Fios)• This role required direct, one-on-one interaction with client independent of any Accenture stakeholders.• Designed, developed, & transitioned training documents for all deliverables including metrics, decks, and reporting logs.• Transitioned deliverables to client in-person and utilizing conference calls over a five week period.Female Diversity Liaison & Hispanic Associate Interest Group (HAIG) Recruiting Events Planner

Somerville, Nj

• Created metrics to track raw material supply in all manufacturing plants. Quantity and time of material shipments were based off of these reports.• Planned weekly, monthly, and annual orders with suppliers to ensure raw material availability on manufacturing floor.• Had ownership of all raw material transfer orders from New Jersey distribution center to all manufacturing plants within the United States, Puerto Rico, and Mexico. • Assisted on data integrity projects to enhance database system and expel obsolete information.

Warren, Nj

• Created Regulatory documents for FDA Registration submission including Power of Attorney, Essential Principles Checklist, and Summary Technical Documentation (STeD).• Gathered required documents from various sources and departments, including Engineering, Clinical Studies, and Quality Assurance in order to submit Registration Applications for LuMend Inc's medical devices within Johnson & Johnson registered countries.• Received training on FDA and individual country’s regulations in order to meet country registration standards and submit product registration applications.

B.S, Chemical & Biochemical Engineering

Activities and Societies: Spanish Minor, Engineers Without Borders (EWB), Society of Hispanic Professional Engineers (SHPE), Minority.

Culinary Arts Proficiency Certificate, Baking And Pastry Arts/Baker/Pastry Chef

Project Management Certificate Of Completion, Project Management

35-hour course to meet requirements to sit for PMP Certification. Included comprehensive educational training project management related.