Dallas Thomas

Freelance Quality Assurance Freelancer & Consultant

186
Location:Jupiter, Florida, United States
Phone: +18016132601
Profile:https://www.freelanced.com/regulatoryaffairs
0
Kudos
3.0
2 Skills
$90
Rate/Hr
Dallas L. Thomas, RAC, MHA, MPA, SSYB, Certified Lead Auditor
West Palm Beach Area, Florida, USA
Mobile/Work Phone +1 801 613 2601
Email: thomas.regulatory@gmail.com

Global Regulatory Affairs & Quality/Compliance/Auditing

PROFESSIONAL PROFILE:

A focused, driven, and passionate regulatory affairs and quality/compliance/auditing professional with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510(k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regulatory Affairs Certification (RAC). Certified Lead Auditor for ISO 13485. Certified Six Sigma Yellow Belt. Experience working with multi-disciplinary teams. Proven organization and time management skills with ability to multi-task under stress. Exposure to national & international regulatory standards such as GMPs, ISO 13485, ISO 9001, QSRs, 21 CFR part 820, Food Drug and Cosmetics Act, RDC 185, and MDD 93/42/EEC, among others. Ability to work well under pressure and handle multiple projects and meet multiple deadlines, while managing priorities accordingly. Prior team building/management and supervisory experience. 2 master’s degrees (Health Administration & Public Administration). Fluent in Spanish and Portuguese.

Experience:
Chemular (subsequently via Hudson Scientific), Michigan - Quality and Regulatory Consultant (July 2016-Present)
? On Site Quality Management Systems auditing, as lead auditor.
? First time implementation of a QMS
? Prepared client companies for ISO Certification Audits
? Assess for Non-Conformities of Quality Management Systems requirements and propose corrective and preventive actions for compliance.
? Client Training on Management Review, External Audit Preparation, All Employee Training on Quality Management Systems
? Technical File Preparation
Axiom Medical, California- Remote Member of UDI Support Team (September 2016) via consulting firm partner company
? Unique Device Identification (UDI) associate consultant
? Assist with Gathering and Uploading data to FDA GUDID before deadline
US Ophthalmic, Miami, FL - Quality and Regulatory Consultant (June 2016-Present)
? Unique Device Identification (UDI) general guidance to client
? Quality Management Systems preparation for 13485 Certification
? First time implementation of a QMS
? Revision to QMS for preparation of 13485 Certification
Face View Mask, Inc., Virginia - Remote Regulatory Affairs Consultant (December 2015-January 2016) via consulting firm partner company
? Premarket Regulatory Assessments
? Label reviews for conformance to US and EU markets
? New Technical File and first time CE Mark for Radiographic Ophthalmology Device
? Review of Applicable Guidance Documents
? Classification of Devices for FDA submission pathway and using rules from MDD 93/42/EEC
Acuderm Inc., Fort Lauderdale, FL- Regulatory Affairs Consultant (March 2016-Present) via consulting firm partner company
? Project manager for team of 5 for EU Technical File Updates and Remediation and response to Notified Body major non-conformities, minor non-conformities and observations.
? Remediating various Tech File deficiencies from notified body audit including Risk Management, Essential Requirements Checklist, Post Market Surveillance, and Labeling
? Coordinated remediation of deficiencies with SMEs in Verification and Validation, Design Controls, Clinical Evaluation
Zimmer Biomet, Palm Beach Gardens, FL- Senior Regulatory Affairs Specialist (January 2016 –Present)
? Preparation and member of ANVISA (Brazilian Agency) GMP Audit Team
? Certified Lead Internal Auditor for ISO 13485 Scope and Internal audits of Quality System
? New Product Development Regulatory Representative responsible for regulatory pathway assessments for FDA 510(k), Letters to File, EU CE Mark Technical Files, Health Canada new applications and amendments.
? Participate as representative in the change control process for proposed changes to product design, supplier and raw material changes, labeling changes.
? Notification of changes to Global counterparts for regulatory impact assessment of changes in all geographies and providing
? Regulatory affairs projects and submissions for class I and II US FDA 510(k) support and Letters to File, Health Canada Submissions (Class I, II, III, and IV) CE Mark (Class I, II and III) and notified body communications.
? EU Technical File Updates and Maintenance and preparation for notified body audit.
? Internal Auditor of the Quality Management Systems per 21 CFR 820 and associated regulations and auditing of multiple internal departments.
? Participated as company audit scribe and crucial audit team member in multiple external audits (Notified Body, Microbiology, FDA prep)
? Regulatory Affairs Database creation of records and maintenance in Oracle, Discoverer, and Application Express Interface
? Creator of online web interface tracker for global regulatory project and task requests from global and internal contacts for internal prioritization.
? Continued support of Latin America geographies as needed.
Zimmer Biomet (after merger), Palm Beach Gardens, FL- Senior International Regulatory Affairs Specialist (January 2015 –January 2016)
? Moved from consultant to employee and continued work on items below, along with additional depth and responsibility in those areas.
Biomet, Palm Beach Gardens, FL- Regulatory Affairs Consultant (July 2014 –January 2015)
? Device Registrations and Device Renewals and tracking in Latin America geographies.
? Internal training to applicable SOPs, protocols, and procedures.
? Assist with Product Change Notifications to global geographies as needed.
? Fixing multiple registration errors done by Ministries of Health and prior internal employee generations.
? Set up registration records of current product registrations for future reference and organization.
? Obtained dozens of first time registrations and dozens of renewals/product sustaining work across the entire Latin America geography and a variety of MOH’s.
? Interfacing with regulatory contacts within company subsidiaries and third party contract distributors in Portuguese and Spanish on a daily basis in both written and spoken formats.
? Researched and translated native-language Latin America regulations to implement a compliant regulatory strategy in harmony with COFEPRIS (MX), ANVISA (BR), DNM (El Salvador), INVIMA (Colombia), DIGEMID (Peru), and ANMAT (Argentina) among others.
? Due diligence to in-country standards and regulations for labeling, pre-market authorization and clearance as well as post-market compliance to in-country requirements.
C.R. Bard, Inc., Bard Access Systems Division, Salt Lake City, UT-International Regulatory Affairs Specialist (October 2013 –July 2014)
? Obtained RAC-Certification (EU) for the scope of all regulated sectors (Pharmaceuticals, Medical Devices, IVDs, etc.) after proven self-study and examination of the Regulatory Affairs Professionals Society (RAPS).
? Successfully drove, coordinated, and completed multiple International Dossier Submissions for First Time Registrations of various product families in the markets of Asia, Latin America, EEMEA, and other core geographies.
? Successfully CE-Marked many products according to the Medical Devices Directive 93/42/EEC including direct responsibility for the Essential Requirements Matrix and the Declaration of Conformity.
? Participated in relevant phases of design control activities as needed.
? Maintained updates to CE technical files for compliance purposes.
? Notified global regulatory counterparts on changes to product design, IFUs, labels, sterilization, etc.
? Maintained direct contact with company representatives around the globe in Asia, Latin America, EEMEA, Europe and Australia.
? RA Representative and Portuguese Translator for Brazil Deep Dive Team in Sao Paulo and Curitiba, Brazil
? Portuguese Translator for Brazilian Nurses at Infusion Nurses Society (INS) Event 2014 in Phoenix, AZ.
C.R. Bard, Inc., Bard Access Systems Division, Salt Lake City, UT-International Regulatory Affairs Associate (January 2012 – September 2013)
? Trained and acted in Capacity of Internal Auditor including training to 21 CFR 820, FDA Quality System Regulations, and ISO 13485. Revised department procedures. Participated in label audits and audits of other departments as called upon by Lead Auditors.
? Successfully drove and completed multiple International Dossier Submissions for First Time Registrations of various product families in the markets of Asia, Latin America, EEMEA, and other core geographies.
? Successfully CE-Marked products according to the Medical Devices Directive 93/42/EEC including the Essential Requirements Matrix and the sign off of CE Declaration of Conformity by management.
? Dozens of international regulatory submissions and a signatory to reformatting/updating/maintaining EU Technical Files and Design Dossiers including, DOC, ERC, and compilation of additional appendices of supporting documents in areas of QMS, Risk Management, Sterilization, Biocompatibility, Design Verification and Validation, Shelf Life, Labeling, etc. in remediation and preparation for a notified body audits. Utilized GHTF (now IMDRF), Team NB Med, and MDD 93/42EEC guidance documents and templates to feed internal formatting and SOPs.
? Participated in relevant phases of design control activities as needed.
? Maintained updates to CE technical files for compliance purposes.
? Notified global regulatory counterparts on changes to product design, IFUs, labels, sterilization, etc.
? Maintained direct contact with company representatives around the globe in Asia, Latin America, EEMEA, and Australia.
? Efficiently assessed product modifications and updates to labeling and IFUs in order to maintain regulatory compliance and approve allowed changes.
? Worked directly with our Portuguese and Spanish speaking counterparts in Brazil and Mexico in order to ensure efficient and productive product submissions, renewals, and sustaining of currently registered products. Lead conference calls with Latin America Regulatory contacts in Portuguese and Spanish.
? Worked directly with multi-disciplinary teams in order to provide regulatory assessment on product modifications, upgrades, label changes, IFU modifications, etc.
? Interfaced directly with cross-functional departments in order to acquire relevant regulatory information from R&D, Quality, Biocompatibility, and Sterilization Departments in order to supply to company business centers worldwide.
? Trained all immediate team members on International Product Submission Dossiers per appropriate corporate and division-level protocol, as I was a founding member of the International RA team.
? Responded to registration deficiencies from ANVISA (Brazil), COFEPRIS (Mexico), CFDA (China), MHLW (Japan), and various competent authorities in Europe.
? Supported hospital tender/contract requests for regulatory information globally.
? Received, prioritized, and concluded hundreds of International Regulatory requests related to implantable port-catheter products such as document requests, hospital tenders, and additional registration activities.
? Supervised and trained two intern staff members who reported directly to me for their projects and workload.
? Participant on corporate-wide committee to update the corporate international dossier protocol.
C.R. Bard, Inc., Bard Access Systems Division, Salt Lake City, UT-Domestic U.S. Regulatory Affairs Intern (April 2011 – December 2011)
? Regulatory representative on US domestic team for Implantable Ports and Catheters for both power-injectable and non-power injectable ports, port kit components and accessories, as well as assisting with regulatory device labeling and packaging requirements for Corporate-level, FDA 510(k) submission support, and compliance to the Food Drug and Cosmetics Act, and 21 CFR 820.
? Regulatory support for both new product development (NPD) and sustaining existing products with their respective modifications (notes to file/notification of change).
? Assisting in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepared required documentation as needed.
? Supporting coordination and review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
? Confirming translations of international regulatory/labeling/marketing documents in the Portuguese and Spanish languages prior to submission.
? Supporting the review of proposals for new product development as well as modification of current medical devices in order to meet regulatory submissions.
? Representing regulatory affairs on product development teams to provide assistance with respect to regulatory requirements and strategy.
? Assisting in development of new product instructions for use/promotional and advertising material including labels and labeling. Reviewing product labeling for compliance with medical device regulations and Division/Corporate Policies.
? Providing marketed product regulatory support for change management activities, product registrations, and business improvement activities.
? Drafting and submitting notifications of change to notified bodies/authorized representatives for international regulatory submissions to BSI, Medicon, and corporate-level international business centers. Compiling support documentation for said notifications of change.
? Verified and updated hundreds of data points for product-line specific regulatory database in order to maintain current and accurate regulatory data from the past and present.
? Acting as support in tracking engineering change notices (modifications to products) in order to verify appropriate regulatory implications in relevant domestic and international markets.
Deseret Industries, West Valley City, UT- Department Manager/Job Coach Trainer (June 2008 – Jan 2012)
? Supervised up to 21 associates concurrently, across 3 departments to reach production and sales goals.
? Coordinated and collaborated on associate hours budgeting to reach Total Budgeted Operations goals.
? Ensured quality standards and policy alignment in production areas.
? Resolved customer issues and concerns and provided 100% customer satisfaction.
? Completed several key company goals regarding new pilot program implementation.
? Utilized MS Office Suite for company operations, forms, schedules, tracking goals, and evaluating product sales.
EDUCATION:
University of Utah-Salt Lake City, UT
? Masters of Health Administration, David Eccles School of Business, 2010-2013 (Emphasis in device regulatory affairs)
? Masters of Public Administration, Center For Public Policy and Administration, 2010-2013 (Emphasis in device regulatory affairs)
Brigham Young University-Provo, UT
? Bachelors of Science in Human Development, 2005-2008
Utah State University-Logan, UT
? General Education Coursework, 2004-2005
(Portuguese Coursework)
(Spanish Coursework)
ADDITIONAL TRAINING:
? FDA Design Controls, Palm Beach Gardens, FL, 2014
? BSI Medical Device CE Marking Seminar, San Diego, CA, 2012
? FDLI Brazil Conference on Medical Device Registration, São Paulo Brazil, 2012
? Latin America Life Science Regulatory Affairs, New Orleans, LA 2013
? Crucial Confrontations Leadership Training, Salt Lake City, UT 2014
? Bard Brazil Deep Dive, RA & Portuguese Translator, 2014, São Paulo & Curitiba, Brazil.
? RAC, Regulatory Affairs Certification—RAPS (Regulatory Affairs Professionals Soc) May 2014
? ADVAMED 2015, International Committee Member, San Diego, CA October 2015
? Lead Auditor Certificate (ISO 13485) issued by BSI, Palm Beach Gardens, FL July 2016
? Internal Auditor Certificate (ISO 13485) issued by BSI, Palm Beach Gardens, FL July 2016
? ISO 13485 Training Certificate issued by BSI, Palm Beach Gardens, FL July 2016
? Six Sigma Yellow Belt Certificate issued October 2016
COMPUTER SKILLS:
? PC & Mac literate
? Proficient in Microsoft Office Suite Software (Word, Excel, PowerPoint, Outlook, Access Database)
? PDF Manipulation, editing, and data extraction in Adobe Acrobat
? Additional Software Experience: MFG Pro, Qumas, Docushare, Final Cut Pro, Master Control, SharePoint, Oracle Database, ETQ Reliance, TipQA, InfoPath, Application Express and Oracle Discoverer.
LANGUAGES:
? Speaks, reads, writes & translates Professional level Portuguese fluently with on the Job Translation Experience.
? Speaks, reads, writes and translates Spanish with high professional fluency.

LIVING ABROAD:
? Lived abroad in Sao Paulo, Brazil for 2 years, establishing Portuguese fluency and leveraging to subsequent Spanish fluency.
REFERENCES:

Additional References Available Upon Request
Skills (2) Rating
Quality Assurance
Consulting