Management Specialist Regulatory Affairs
Resume:
Shawn Stillwagon
Fort Worth, TX 76244
**************@*****.***
Objective
To utilize my regulatory experience within the medical device and/or pharmaceutical industries to positively impact an organization and contribute to the overall organizational success.
Employment
2019-2022 Content Management Specialist (Global) (Contractor)
Alcon Laboratories, Inc., Fort Worth, TX
Manage implementation of Medical Device Regulation (MDR 2017/745) labeling transition for all franchises by:
Managing initial global text translation requests
Review text for accuracy and liaise between Global Regulatory Affairs to obtain required approvals
Support miscellaneous text requests (new product launch, product site change, redress, etc.)
2015-2019 Regulatory Affairs/Quality Analyst and Global Support
Joerns Healthcare, Arlington, TX
Managed Medical Device Regulations 2017/745 (MDR) implementation by:
Performed gap analysis of CE Technical File documentation
Vigilance and post-market surveillance plan
Obtained CE Mark
Successfully implemented Unique Device Identifier (UDI) for Class II devices, including:
Met requirements of US Food and Drug Administration (FDA)
Updated product labeling
Managed manufacturing requirements
Report labeling characteristics to Global Unique Device Identifier Database (GUDID)
Obtained Medical Device Single Audit Plan (MDSAP) certificate
2013-2015 Global Regulatory Affairs (Re-registration, Product Support) (Contractor)
Alcon Laboratories, Inc., Fort Worth, TX
(04-22-13 – 01-30-15) Supported Global Regulatory Affairs (Vision Care and Pharmaceutical franchises) re-registrations, including:
Coordinated with global affiliates to collect needed documents from applicable departments/sites,
Ensured filing timelines were met
Provided needed regulatory certificates, including Certificate of Pharmaceutical Product (CPP), Certificate of Foreign Government (CFG) and Certificate of Free Sale (FSC)
(03-15-15 – 07-01-15) Supported global labeling remediation project by coordinating updated labeling between affiliates and Global Regulatory Affairs for approval and production implementation.
2012-2013 Regulatory Affairs and Quality Assurance Specialist
MPM Medical, Inc., Irving, TX
Implemented the Quality System to comply with Part 21 Code of Federal Regulations, Part 820, including:
Created Quality Management System documents
Purchasing Controls (Supplier qualifications and Supplier files)
Managed Medical Device Reporting
Prepared Management Reviews
Conducted Supplier and Quality System audits
Maintained Corrective and Preventive Actions (CAPAs), complaints and Adverse Events (AEs)
Conducted labeling and website reviews
Implemented and managed archiving system
2011-2012 Corporate Quality Assurance
LifeScience Logistics, DFW Airport, TX
Performed internal audits and reported findings to Senior Management
Authored, reviewed and approved Standard Operating Procedures (SOPs) and Work Instructions (WIs) for clients Managed the corporate document program; including, created and distributed controlled documents to satellite branches
Performed support warehouse functions/managed TempTale data
2007-2011 Quality Systems
Ideal Implant Incorporated, Irving, TX
Created and implemented the Quality System to comply with Part 21 Code of Federal Regulations, Part 820, including:
Quality System Records (QSR)
Prepared and conducted Management Reviews
Qualified Suppliers
Created Purchasing Controls
Performed supplier and quality system audits/created and maintained Supplier Files
Complaint tracking system and Corrective and Preventive Actions (CAPAs)
Managed packaging validation
Clinicals and Regulatory Filings:
Prepared FDA submissions, including; Investigational Device Exemption (IDE), IDE Amendments and Supplements, modular Pre-market Approval (PMA for Class III device) and Annual Reports
Coordinated lab testing to support IDE filing
Reviewed and approved batch releases
Managed clinical trial supplies and inventories (third-party manufacturers, sponsors and clinical sites)
Hosted FDA Bioresearch and Monitoring (BIMO) audit and managed clinicaltrials.gov site
Regulations Part 21 Code of Federal Regulations, Parts: 210, 211, 801, 803, 806, 807, 812, 814, 820 and 830
Medical Device Regulations 2017/745, trained 2019
ISO 13485:2016, trained August 2017
Therapeutic Goods Administration (TGA) – Australia
Medical Device Regulations SOR/98-282 - Canada
Medical Device Single Audit Plan (MDSAP)
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