Kimberly Richards Email and Phone Number

-Leading a team with a primary focus on U.S. FDA, EU MDD, and EU MDR Regulatory Affairs, Biocompatibility Assessments, and Change Control.-Provide Regulatory support throughout design and development process for new product development and enhancement/improvement projects. Collaborate on engineering reports to provide regulatory feedback.-Prepare regulatory strategies and review technical documents.-Collaborate with stakeholders on scope of work and notification requirements for changes related to existing products, processes, and operations.-Prepare and facilitate 510(k) and De Novo submissions, EU technical documentation for conformity assessments, and assist with responses to regulatory body queries. Communicate and coordinate deliverable needs with engineering teams.-Lead Quality projects related to state-of-the-art conformance for UDI and Biocompatibility subject areas.-NAMSA-certified Biological Safety Specialist trained to complete Biological Evaluation Plans and Assessments. -Author and review biological safety assessments for new products and proposed changes to existing products. -Collaborate with toxicology consultants and certified test labs to coordinate biocompatibility test needs and completion of toxicological risk assessments. -Labeling expertise with concentration in FDA, EU, and ISO requirements and submissions for UDI compliance. -Develop Regulatory department procedures, work instructions, and templates based on gap assessments.-Support audits with Notified Body. Understanding of and involvement with CAPA processes.

-Focus on U.S. FDA Regulatory Affairs, Biocompatibility Assessments, and Labeling.-Provide Regulatory support on new product development and enhancement/improvement projects. -Experience with preparing regulatory strategies and reviewing technical documents.-Collaborate with Change Control and Rest of World Specialists on scope of work and significant change notification requirements for changes related to existing products, processes, and operations.-Prepare Traditional 510(k) submissions and assist with responses to Notified Body queries. Coordinate deliverable needs with engineering teams.-Lead Quality projects related to UDI and Biocompatibility conformance.-Labeling and UDI expertise with concentration in regulatory strategies and submissions for UDI compliance. -Proficient with FDA GUDID submission requirements; familiar with EUDAMED UDI submission requirements.-Knowledge in FDA, EU, and ISO requirements for Labeling, including UDI, direct marking, product labels, and instructions for use. -Develop Regulatory department procedures, work instructions, and templates based on gap assessments.-Support audits with Notified Body. Understanding of and involvement with CAPA processes.-NAMSA-certified Biological Safety Specialist trained to complete Biological Evaluation Plans and Assessments according to ISO 10993 requirements.

-Focus on Labeling, UDI, and Domestic (U.S.) Regulatory Affairs.-Prepare regulatory strategies and submissions for UDI compliance.-Knowledge in requirements for Labeling, including direct marking, product labels, and IFUs. -Development of procedures and work instructions related to UDI and Labeling.-Provide Regulatory support on new product development and enhancement/improvement projects.-NAMSA-certified Biological Safety Specialist trained to complete Biological Evaluation Plans and Assessments according to ISO 10993 requirements.-Experience with drafting 510(k) submissions, preparing regulatory strategies and commercial release authorizations, and preparing and reviewing General Safety and Performance Requirements/Essential Requirements checklists.

-Teaching assistant and project management liaison for the Biomedical Engineering Senior Design course.-Evaluate and grade professionally written memos and technical reports based on background research and device testing methods. Offer opinions and recommendations for additional resources the team may need in order to best achieve the proof of validity, completeness, safety, and effectiveness of their device.-Attend weekly team meetings to facilitate discussion amongst team members and their supervisor and customers.-Create new additions to the UR BME curriculum related to FDA database searches and design of experiments for safety and effectiveness.

-Employed as an outdoor snack-bar assistant for two summers, then promoted to snack-bar manager; worked 15-35 hours each week. Responsible for taking orders, cooking, and serving food and drinks to members.-Assisted with administrative duties such as staff scheduling, conflict management, taking inventory, and restocking. Helped train new employees. -Required excellent communication, time-management, efficiency, and teamwork skills, in addition to having the ability to be flexible and accommodating to members and staff.

Assist head coaches with setting up and running drills and demonstrating skills. Teach beginners (ages 7-16) the fundamental skills required to play field hockey.

-Led a small group of students in weekly exercises for the Introduction to Programming (CSC161) course.-Graded quizzes and exams.

Gained customer service and retail experience.

Took detailed notes for various courses and submitted them online for pre-approved student use.Past courses include:-Calculus II and III (MTH 142 and MTH 143)-Linear Algebra with Differential Equations (MTH 165)-Physics: Electricity and Magnetism (PHY 122)-Biosystems & Signals (BME 210)

Tasks included:-Responsibility of designing an updated filing system for different types of files and then explaining my thought process so the rest of the office understood the system.-Extracting data from ledgers and entering them into a University database.-Filing ledgers and contracts by division and in chronological order.-Running errands throughout the hospital to pick up and/or deliver materials.

Assisted directors with children of ages ranging sixth grade to eighth grade during the summer day camp.Responsible for leading small groups, introducing new activities, ensuring the safety of the children at all times.

Hired to replace a teacher who left the after school care program.Helped take care of children ranging from pre-school age to sixth grade. Responsible for watching over small groups, leading activities, and ensuring the safety of the children at all times.