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STERIS EndoscopyProduct Labeling Supervisor
Sep. 2023Conroe, Texas, United States• Provide direction on label management processes and project prioritization and execution.
• Create and modify labeling for product instruction for use (IFU) documents, labels, cartons,
and other related materials ensuring that they meet all medical, legal, and regulatory
requirements for medical devices following the established design format, labeling style
guidelines and branding guidelines.
• Lead activities for new and updated labels from creation, through First Article Inspection (FAI)
through the change control process.
• Monitor changes in labeling regulations in the US and/or abroad and ensure that labeling
meets all medical, legal, and regulatory requirements.
• Confer with label package change initiators to assess business needs and to determine their
requirements in order to help solve problems in an innovative, cost effective and timely
manner.
• Ensure all requested projects have appropriate labeling resources assigned to enable on-time
completion of project goals.
• Contribute to the development of solutions and best practices for labeling initiatives, including
recommending activities involving legacy systems, process improvement, country-specific
requirements, labeling standards and regulations, and labeling stakeholders.
• Communicate with vendors regarding ongoing labeling operations.
• Work with outside vendors on content translations for labels and I FUs
• Control and manage numerous product labeling project tasks that culminate in release to
production via the engineering change process.
NAMSASenior Regulatory Consultant, IVD
Jul. 2021 - Jul. 2023Minnesota, United StatesExamined and assessed various clients IVD medical devices for compliance to FDA and EU regulations, for the marketplace. Provided comprehensive details regarding investigational product(s) and high level understanding of the IVD medical device development process. Delivered strategic direction and guidance for NAMSA clients, particularly as it relates to product development. • Assessed IVD devices to determine device classification and the best route for getting the product on US market; Laboratory Developed Tests (LDT) and/or FDA submissions (510K, De Novo, PMA, CLIA-Waived Dual Submission, Over-the-Counter (OTC), or Breakthrough Designation).
• Developed a strategic regulatory plan for a coagulation device series which coincided with the FDA Replacement Reagent Instrument Family guidance. This strategy provided 3 options for the development, test criteria (analytical and clinical), and 510K submissions as well as an estimated timeline of each pathway. Also, tables of the advantages and disadvantages to each strategy was detailed.
• Achieved Emergency Use Authorization (EUA) approval with the submission of a clients COVID-19 rapid point-of-care (POC) IVD test
• Collaborated with consultant colleague in webinar providing the details on the topic of Transitioning from EUA to 510K for IVD Products
• Featured with consultant colleagues in podcast discussion on differences between Software in Medical Devices (SiMD) vs. Software as Medical Device (SaMD)
• Reviewed and developed FDA pre-submission and submission documents for the following: 513(g), 510K, and De Novo pathways
• Performed training presentations to colleagues on the US FDA Unique Device Identification (UDI) Basics and the EU UDI versus the FDA UDI
Sysmex America, Inc.Sr. Regulatory Affairs Specialist, Labeling
Jun. 2016 - Jul. 2021Lincolnshire, ILThe Sr Regulatory Affairs Specialist is responsible for supporting compliance to FDA, Canada and Latin America regulations, listings and licenses and applicable international regulations. The individual will coordinate, compile, and submit regulatory documents to FDA and other appropriate regulatory agencies according to requirements. The individual will provide support for all regulatory compliance activities including change control impact assessment, product labeling and promotional material review, Unique Device Identifier (UDI) activities and other regulatory tasks as needed. The Regulatory Affairs Specialist will report to the Director of Regulatory Affairs. Essential Duties and Responsibilities: Coordinates, compiles and submits U.S, and/ or International regulatory submission of registered/licenced product listings, creation regulatory assessments for design change/change control, filing and/or updating of UDI records, application of Certificates to Foreign Government (CFG) submissions, and product label review.
Sysmex InosticsRegulatory Affairs Specialist, Labeling
Mar. 2015 - Jun. 2016Mundelein, IllinoisResponsible for creating and revising labels in compliance with US and International Regulations and maintaining the effectiveness of the quality system. • Expert in IVD label content development and composition. Proficient in domestic, international and EU CE marking. Proficient with harmonized label standards and harmonized label symbology.
• Construct IFU and labeling layouts for accessories, instrumentation, vials and kit labels.
• Compose content for package inserts and kit/vial labels into templates using desktop publishing software (InDesign) and design software (Photoshop and Illustrator) for FDA submissions and on-market products.
• Ensure labels are compliant to Globally Harmonized System (GHS), BS ISO 9001, ISO 13485 symbolization codes and support global registrations. Familiar with EU IVD Directive, FDA label requirements for IVD and some international requirements. Familiar with translation requirements.
• Manage, coordinate and track documentation to completion with other functional areas, verifying documentation accuracy. Establish filing system for labels and related documentation.
• Lead in labeling change control efforts and medical writing/label standard operating procedure review and approval.
• Project lead in label/IFU development and implementation efforts
• Support in various medical writing and RA activities
Abbott MolecularLabeling Specialist
Mar. 2010 - Mar. 2015Responsible for implementing and maintaining the effectiveness of the quality system. Build content for package inserts and kit/vial labels into templates using desktop publishing software (InDesign) and design softwares (Photoshop and Illustrator). Communicates, coordinates and tracks labeling and documentation with other functional areas.
Focus Products Group International, LLCFreelance Graphic Designer
Feb. 2010 - Feb. 2010Vernon Hills, ILDesigned 2010 catalogs for the AMCO Housewares and Chicago Metallic product lines.
Also created packaging for Chicago Metallic products.
College of Lake CountyAdjunct Adobe Software Instructor
Aug. 2009 - Feb. 2016Grayslake, ILInstructing professionals in Adobe programs that include: Photoshop, Illustrator and InDesign.
• Teaching students to use layers, layer effects and filters to create special effects. Use painting tools and blending modes to create shading effects in Photoshop Level 1.
• Focusing students on color management, creating animation and automating tasks. Navigating from the creation of images to image management for optimal web and print display in Photoshop Level 2.
MABIS DMI HealthcareGraphic Designer
Dec. 2007 - Aug. 2009Created artwork that includes package, magazine ad and multimedia designs.
• Designed innovative and modern package artwork for new line of blood pressure monitors.
• Created all print-based and multimedia artwork for tradeshow campaign promoting the company’s new e-commerce website.
AquentGraphic Designer
Mar. 2006 - Nov. 2007Designed collateral material for various companies including Fortune 500 organizations.
• Built and revised layouts as a Deep Scrub team member for Grainger catalogs in a fast paced environment.
• Built and revised layouts for Staples catalogs while providing a quick turn-around in a fast-paced environment.
• Created and revised various educational materials for a RR Donnelley subsidiary, Anthology.
D3TS DesignFreelance Graphic Designer
May. 2003I have been drawing, for what seems to be, my entire life. However, I've been designing professionally for over 20 years. I have experiences in logo, package, advertising and web/multimedia design. As a contract freelancer, I have designed for various Fortune 500 companies that include: Quill (Staples), Grainger, R.R. Donnelley and Abbott Laboratories. Although I have created for big name companies, I am more than willing to lend my talents to small businesses. I also offer my expertise as a part-time Adobe Software Instructor. Teaching individuals to learn design programs that will provide them with skills to that helps excel their positions in the workforce is an honor. It is my dream and goal to become a professor of graphic design where I might assist younger designers toward a successful career in visual communications and arts.
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