Mary A Booth

Richardson, Texas 904-***-**** ad461h@r.postjobfree.com

Regulatory Affairs Specialist

Regulatory Affairs / Quality Assurance Specialist of medical devices adhering to FDA regulations, and ISO standards, a labeling professional with a positive attitude and strong work ethic, supporting domestic, global, and international registrations and submissions by supplying documents, preparing, compiling, and submitting document packages for regulatory affairs, compliance guidelines and inspections. Interfaces with geographic partners to ensure submission success. Maintains regulatory databases and technical files. Review materials such as labeling, marketing materials, or user manuals to ensure compliance with regulatory agency requirements and laws. Supports projects and cross-functional teams. Maintains current knowledge of existing emerging global regulations, standards, and laws.

Education

Bachelor of Science in Business Management: University of Phoenix 2012

Professional Experience:

GEHC / Life Care Solutions

Regulatory Affairs Specialist ll / Consultant Mar 2022-Mar 2023

Provided Regulatory oversight and control for Life Care Solutions projects, including global transfers and product development, for several international countries, provided RA support for international planning, submissions, notified body, and program implementation, worked closely with a cross-functional team, and communicated to leadership. Reviewed, edited, and proofread labeling changes and regulatory documentation to ensure accuracy and compliance. Tracked all relevant ongoing product registrations, identifying and communicating major milestones, and constant communication with geographic partners to ensure submission. Applied regulatory requirements and their impact on submissions for pre-post market approvals, ISO standards, Quality Management System, (QMS), and International Standard Organization (ISO, governing body). Software apps used: Microsoft, TORUS, Excel, PowerPoint, Agile Labeling system, Windchill, My Workshop (MWS), BOX

applications. Completed training with GEHC Documentation Controls and Training processes, training with MWS Doc Central and GE Learning process, Documentation Controls and Training processes, QMS documents, and training with the TORUS application, training was completed on or before the deadlines.

DJO LLC, Mar 2021 – Oct 2021

Regulatory Affairs Specialist / Consultant

Executed global product registrations (GPR) for intent to register products. Software apps used: Agile Labeling System, Emergo database, MS Office, Excel, System Applications & Product (SAP), Enterprise Resource Plan (ERP), proofreading and editing documents for distribution and shipping, and providing updating and registering to sports medicine documents.

Zimmer-Biomet Jun 2017-Apr 2020

Regulatory Affairs Specialist l

Supported and project-managed (assigned) remediation change while supporting EU-MDR reports also, registrations for Class lla, Class llb, and Class lll medical devices. Managed submission and international registrations fulfilled international regulatory requests (IRR), documents provided for international and global registrations, reviewed labeling changes and IFU (information for use), for product packaging purposes for Class IIa (low-risk implantable), Class llb (medium-risk implantable), and Class lll (high-risk implantable) medical devices while supporting projects changes, Software apps used: ERP/SAP, JD Edwards, Robar, RIMS (veeva vault), Windchill, PowerPoint, Excel, MS Office, FDA / Emergo databases. International and Global MoH for countries' registrations and compliance with the country's requirements. Accomplished completing projects promptly, to get large revenue for the company and stakeholders. Completing all projects on time.

OsteoMed Jul 2005 – Feb 2011

Quality Inspector

Inspection of medical devices, responsible for receiving and inspection of raw materials for quantity and appearance for the manufacturing of plates, screws used for implants, Class l (instruments), Class lla (low risk implantable), Class llb (medium risk implantable), Class lll (high-risk implantable), also examined incoming products from vendors, Class l instruments used (for inspecting incoming goods from vendors): calipers’, gage pins, blueprints, comparators, micrometers, height gages (manual/digital), some training with and on CMM (Coordinated Measuring Machine), and labeling. Submitted application for CN (change notices) and reviewed changes to sustaining products, to follow FDA regulations and guidelines to ensure proper compliance and usage of the device. GMP (Good Manufacturing Practices), cGMP (current Good Manufacturing Practices), Quality Assurance Documentation and Batch Record Training, Basic Supply Chain training, and Certified Quality Improvement training.

OsteoMed Feb 2011 – Apr 2016

Regulatory Affairs Associate

Supported new and sustaining products while preparing change notices for EU-MDR reporting, assigned and managed registrations and submissions for several countries including but not limited to Asia Pacific, Brazil, LATAM, Mexico (etc.), for Class l instruments, Class lla (low-risk implantable), Class llb (medium risk-implantable), and Class lll, (high risk-in implantable) medical devices, and instruments. Compiled, supplied, and reviewed documents labels, and submission documents for accuracy before being sent with packaging for any submission or registrations. Update to Technical files, SOPs (Standard Operations Procedures), DOPs (Department Operation Procedures), DHF (Design History Files), and STEDs (summary technical electronic document). A licensed and Bonded Notary for the Regulatory Affairs dept for four years with OsteoMed. Other project responsibilities were preparing CFG (Certificate of Foreign Government) for Apostille, Legalization, and Notarization if needed to be supplied to countries for registrations. Software apps used: MS Office, Excel, PowerPoint, Agile Labeling System, ERP (Enterprise Resource Plan), SAP (System Application and Product Tracking) system, FDA (Food and Drug Administration) website, and Emergo database.

Medtronic Sept 2002- Jul 2005

Quality / Labelling Inspector

Inspected finished goods and the sealed integrity of packages for the shipping of products and labeling for any changes. Audited and analyzed the inventory amount of product, not limited to data collecting, involved with CAPAs in the event of discrepancy if an event of product recalls occurs.

Other resources associated with job performance:

FDA /Emergo Guidelines / Database

ISO standards: (ISO 13485 Quality Management System)

ISO 9001:2006 (ISO Management System)

ISO 15223:2016 (symbols)

CFR 820 / 21 (code of federal regulations)

IEC 60601-1 (medical electrical equipment)

Certifications:

GMP (Good Manufacturing Practices)

cGMP (current Good Manufacturing Practices)

Quality Assurance Documentation

Batch Record Training

Basic Supply Chain Certified

Quality Improvement

References available upon request:

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