Debra Vigil

Debra Vigil Email and Phone Number

Senior Associate, Regulatory Affairs @ ICU Medical
Debra Vigil's Location
St Louis, Missouri, United States, United States
Debra Vigil's Contact Details

Debra Vigil personal email

n/a
About Debra Vigil

Quality Assurance and Regulatory Affairs professional with 15 years' experience, including establishing and maintaining ISO 13485 Quality Management System and CE Mark certificates for standalone software medical devices. Successful 510(k) submission for class II moderate concern device cleared in under 30 days. Lead Auditor certification for ISO 13485 and EU MDR. Head compliance efforts for HIPAA and other privacy and security related regulations and measures. Create and deliver related training.

Debra Vigil's Current Company Details
ICU Medical

Icu Medical

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Senior Associate, Regulatory Affairs
Debra Vigil Work Experience Details
  • Icu Medical
    Senior Associate, Regulatory Affairs
    Icu Medical Jun 2023 - Present
    San Clemente, Ca, Us
    Provides regulatory support and expertise associated with global and US registration of device products for assigned portfolios, including in-depth analysis of the requirements and tracking of deliverables. Supports creation of global regulatory strategies and assists in execution including creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management.
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  • Radialogica Llc
    Director Of Quality Assurance And Regulatory Affairs
    Radialogica Llc Jan 2014 - Mar 2023
    St Louis, Missouri, Us
    Established and maintain Quality Management system and certifications under ISO 13485 and CE Mark/EU MDD/MDR. Handle relevant regulatory filings, including 510(k) pre-market application for new software product (cleared FDA review in under 30 days).
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  • Elekta
    Quality Assurance Engineer
    Elekta Mar 2011 - Jan 2014
    Stockholm, Se
    Quick to evaluate circumstances and seek necessary information or resources to secure a full understanding of the situation and/or requirements to be resolved. Very reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances, while being creative, thorough, and persuasive enough to effectively maintain the state of control required for Quality System effectiveness. As directed by Quality Assurance management, responsibilities include: • Drafting procedures and documents, assisting employees with the understanding and performance of their Quality System responsibilities • Analyzing the need for process changes • Internal auditing, employee training • Document revision, document control • Performing and documenting software and component validation • Evaluation and interpretation of regulatory and standards schemes applicable to the organization.
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  • Elekta
    Process Analyst/Writer
    Elekta Sep 2010 - Mar 2011
    Stockholm, Se
    Created business process flow documentation for ERP implentation in the St. Louis division:. Interviewed business owners and Subject Matter Experts, captured current and future state buniness processes, identified gaps and pursued resolution. Served as Testing Administrator by creating testing scenario masters for functional leaders to populate, ensuring conversion to test plans and scripts, issue tracking, success/failure documentation. Programs used include Microsoft Visio, Word, Outlook, Excel, SharePoint, SteelRay (project planning).
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  • Malisko Engineering, Inc.
    Technical Writer (Consultant)
    Malisko Engineering, Inc. Apr 2010 - Aug 2010
    Saint Louis, Mo, Us
    Created Design and Validation documentation for major client implentations in the food and pharmaceutical industries: Document types included Detailed and Functional Design (DDS and FDS), User Requirement Specifications (URS), Internal and Operational Qualifications (IQ and OQ), and testing scripts. Programs used include Microsoft Word and Excel, reading CAD diagrams and electrical blueprints as necessary
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  • Express Scripts
    Technical Writer (Contractor)
    Express Scripts May 2009 - Jan 2010
    St. Louis, Mo, Us
    Performed gap analysis of call center knowledge base for major client re-implementation (Tpharm). Met with cross-functional teams to analyze informational asset needs. Designed and developed solutions that encompassed retiring outdated materials, revising and creating content, and tracking actionable items. Ensured business owners and SMEs reviewed and approved documentation. Worked with project management to gain alignment across affected business departments. Programs used include Contribute CS3, Dream Weaver 8, Word, Outlook, Excel, NetMeeting, SnagIt, Visio, SharePoint, and Knova Knowledge Management Suite.
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  • Savvis
    Technical Writer
    Savvis 2007 - 2009
    Monroe, La, Us
    Establish corporate technical writing standards; develop and deliver training on same. Create, edit, and maintain templates and techncial documentation for corporate wiki; create and maintain corporate terms glossary. Analyze and recommend media and tools for documentation use. Analyze, gather information from developers and subject matter experts, and document applications and products for unternal and external users. Consult on projects as needed across functional team lines. Programs used include Word, Outlook, Excel, PowerPoint, SnagIt, Visio, Confluence wiki, Help & Manual 3.0, Camtasia media suite.
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  • Express Scripts, Inc.
    Knowledge Management Functional Lead
    Express Scripts, Inc. Aug 2005 - Sep 2007
    Knowledge Management Information Analyst (Functional Lead)Performed business analysis of current support center knowledge base. Created, edited, and maintained templates and content of new knowledge base using Information Mapping methodology. Created HTML documents. Documented analysis and creation processes. Managed 2-3 technical writers assigned to projects. Some project management responsibilities. Programs used include Word, Outlook, Excel, NetMeeting, SnagIt, Visio 2003, Macromedia Dream Weaver 2004 MX/ DreamWeaver 8, Fireworks, and Knova KM Suite.
  • Neteffects
    Technical Writer (Contract To Sbc)
    Neteffects Mar 2005 - Aug 2005
    Chesterfield, Mo, Us
    Developed procedural training materials, including job aids and help screens. Created and maintained online training courses. Managed content of Web based applications for several intranet sites, based on analysis of requirement specifications provided. Programs used include PowerPoint, Producer, and Dreamweaver MX. Created technical documentation for Middleware products developed by different internal organizations. Documented leadership meetings. Programs used include Visio 2003, Word, Outlook, NetMeeting, Excel.
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Debra Vigil Skills

Visio Software Documentation Technical Writing Editing Business Analysis

Debra Vigil Education Details

  • Washington University In St. Louis School Of Law
    Washington University In St. Louis School Of Law
    Law
  • Washington University In St. Louis
    Washington University In St. Louis
    Philosophy

Frequently Asked Questions about Debra Vigil

What company does Debra Vigil work for?

Debra Vigil works for Icu Medical

What is Debra Vigil's role at the current company?

Debra Vigil's current role is Senior Associate, Regulatory Affairs.

What is Debra Vigil's email address?

Debra Vigil's email address is de****@****kta.com

What schools did Debra Vigil attend?

Debra Vigil attended Washington University In St. Louis School Of Law, Washington University In St. Louis.

What skills is Debra Vigil known for?

Debra Vigil has skills like Visio, Software Documentation, Technical Writing, Editing, Business Analysis.

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