Kelly Langkilde Email & Phone Number

Acton, Massachusetts, Us

London, Gb

Certified regulatory specialist in the areas of ISO13485:2016, 9001:2015, 14971:2019, EU MDD/MDR, MDSAP and Leading Medical Device Audits. Provide professional level planning, communication, and improvement recommendations for clients to continue with required certifications based on regulation requirements. Broad device knowledge base working with Class I, II and III devices (i.e. active/nonactive, implantable/non-implantable, sterile/non-sterile, cardiovascular, vascular, respiratory, software/hardware medical systems, mobility, surgical, patient care and many other device types).Position Highlights:• Lead Quality Management System Assessments for large global regulatory clients and team mentorship to junior level regulatory associates. Providing recommendation for improvements.• Review Technical Files/Master Device Files, FDA/510k, EU MDD/MDR Submissions, QMS Review/Assessment, Improvement, Management.• Write, edit and review concise regulatory reports for global clients and regulatory submissions.

Valley City, Ohio, Us

Execute domestic and international online and hard copy instructional technical publications and graphic designs for powered products and equipment. Provide world class support for over 60 brands of products worldwide. Continually improve processes and budgets by applying Lean Methodologies to improve business needs on a global basis.Position Highlights:• Currently, manage 8-10 highly diverse global technical and design team members.• Provide ongoing support and professional development for direct reports.• Monitor and manage departmental budgets. Deliver continual cost savings initiatives.• Assign and monitor workload for instructional design and graphic design projects.• Develop workflows and business processes for using change control system. Monitor, approve, create or delegate all change requests.• Provide review/editing suggestions and approval for all user related technical documents, including brand/safety labeling for multiple product divisions.• Oversee communication of cross-functional teams. Provide weekly forum to discuss open risks for all business stakeholders to ensure projects are on-time and within budget.

Elyria, Ohio, Us

Managed day to day operational and tactical aspects of the legal/regulatory documentation submissions, regulatory teams, design/writing teams. Improved timelines and usability of end-user documentation by establishing an improved content translation management. Established global standards, workflows and managed the implementation of XML/DITA style document development within the team. Fostered strong relationships with business stakeholders. Position Highlights: • Managed regulatory submissions for 510k, EU and Global regulatory/legal submissions for medical devices. Created/Reviewed Technical File/Master Device Records. Worked with global agencies to ensure global submissions were managed and submitted properly.• Achieved performance through clearly set objectives; engaged timely and meaningful performance appraisals and discussions. • Implemented new CMS system using Arbortext and Windchill, Adobe, IsoDraw and Windows tools to create and manage our technical file and user documentation library. • Identified process improvement opportunities for on-going solutions to reduce document development timelines, reduce departmental operating costs and increase procedural efficiencies. • Extensive involvement with implementation of new authoring and translation tools. • Fostered a team environment which encouraged taking on new initiatives, being create, and developing skills. • Managed budgets, initiated multiple cost reduction initiatives. • Engaged communication between regulatory, technical writers and engineering teams to design and develop high-quality end-user documentation, IFUs and illustrated designs. • Managed technical documentation process to ensure documentation was completed on time for each release cycle. • Managed projects based on regulatory standards (ISO, FDA, MDSAP, EU MDD, ANSI) driving change for product-based risks. • Supported FDA and third party audits. • Implemented Content Management System (CMS) and DITA methodology.

Elyria, Ohio, Us

Cleveland, Oh, Us

Responsible for deploying and integrating applications and product solutions within client servers through virtual, in person, and phone installation and support. Wrote detailed technical operation and maintenance manuals for the Clinical monitoring and installation. In charge of producing all engineering documentation, such as quality assurance test reports, plans, software design and requirement specifications, software matrix and installation procedures.• Perform quality testing and reporting on all beta products, application, and software.• Perform updates to internal firmware, hardware, software, client web applications, and databases as needed. • Perform installation and configuration of client software applications and server integrations.• System integration with MySQL/MSSQL databases, network and web UI applications.• Work closely to integrate technologies such as Windows 2003-2008 Servers, SQL Servers, and .NET Framework.• Gathered client’s technical requirements to implement product solutions specific for each client.• Produce all product support literature, including training material, operator’s manuals, service manuals, and quick guides.• Assist with internal and external client training both in person and virtually.• Perform research to analyze, troubleshoot and resolve day-to-day hardware and software application issues.• Work with a variety of network technologies, clinical applications, NET, SQL web applications, and databases. • Research, track and interpret changes in technology to provide technical support to the service organization. • Support internet technologies, including principles and practices of networking; Windows operating systems; DNS and Web services.

Elyria, Ohio, Us

Provided ongoing support and project management for high profile departmental projects, time management, planning, resource tracking, establishing workflows, review writing, and implementing/developing new projects and procedures.• Provided administrative support for department SharePoint site, producing, designing, and implementing departmental solution.• Implemented new SharePoint Department Wiki and Blog to enhance departmental communication.• Created new SharePoint workflow and process for document review and approval. • Designed/managed the development, standardization and implementation of database solution for Designers to interact with customer service.• Developed training documents and conducted training sessions to help users better understand company systems and products.• Produce and maintain technical documentation, domestically and internationally.• Manage cost, timeline, analysis and review of multiple translation vendor and linguist’s multilingual translation projects in print and digital formats.

Elyria, Ohio, Us

Designed, revised and implemented new catalogs to allow customers to service Invacare products.

Elyria, Ohio, Us

Started at Invacare back in 1996, working in manufacturing in the electronics department.

I have worked on multiple projects involving the design and production of websites for small companies. I also provide ongoing management of the sites providing maintenance and updates as needed.

Master Of Business Administration (M.B.A.), Management

Bachelor'S Degree, Information Technology And Minor Web Design

Associate'S Degree, Computer Programming