Monica Patterson Email & Phone Number

Regulatory writing of device information for combination productso 3.2.Ro Device Master File (MAF)o Type B, C, and D Meetingso Pre-IND, IND, and NDA submissions

Create and review documentation for combination products such as pre-filled syringes and auto-injectors:o Use Specifications, User Needs (UN), Design Input Requirement (DIR), and Design Verification and Validation (DV&V)o Risk Management Plans (RMP), Hazard Analysis (HA), Failure Modes and Effects Analysis (FMEA), and Risk Management Report (RMR)o Human Factor (HF) Plans and Summary Reportso 5.3.5.4 and 3.2.R Regulatory Draftingo Test Method and Process Development, Validation Protocols, and Validation Reports

Bloomington, Indiana Area

• Created Design History File (DHF) and Risk Management Documentation to support Pilot Process for Continuous Flow Manufacturing for Star Product Line estimating annual global production savings of ~$1.4 million in 2022• Created and oversaw creation of DHF and Risk Management Documentation for the EUMDR transition targeting ~$59 million protected annual sales• Mentored and onboarded co-ops, contractors, and newer employees to secure a target of ~$29.2 million protected annual sales across all vascular access and lead management product lines• Oversees ~$71 million annual sales globally

Bloomington, Indiana, United States

• Led 7 product lines to submission to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA); Secured Market Authorization of 45 products in the Japanese market- Protected ~$300,000 in balloon catheter sales in 2019- Protected ~$700,000 in wire guide (guidewire) sales in 2020• Led 3 product lines to submission to the South Korean Ministry of Food and Drug Safety (MFDS); Secured Market Authorization of 35 products in the South Korean market- Protected ~$26,900 in balloon catheter sales in 2019- Secured KGMP Certification for Bloomington Manufacturing Facility protecting ~$45 million sales in 2020 across all product lines• Coordinated and led monthly test lab meetings to facilitate communication with testing personnel for all APAC regulatory compliance projects protecting ~$23.2 million annual sales

Bloomington, Indiana

• Created DHF and Risk Management Documentation- Design Control Traceability Tables (DCTT / DRT), Use Specifications, User Needs (UN), Business Needs (BN), Design Input Requirements (DIR), Design Outputs (DO), and Design Verification (DV&V)- Risk Management Plans (RMP), Clinical Effects Analyses (CEA), Failure Modes and Effects Analyses (FMEA), Benefit Risk Analyses (BRA), and Risk Management Reports (RMR)

• Support individuals emotionally and listen to their thoughts and concerns• Answer questions, assist other listeners in chats, and suggest improvements for the site to better support members and guests.• Propose projects, manage listener and member teams, train listeners to enter higher management positions.• Assist the community with conflict resolution

• Designing and fabricating microfluidic devices with laser micromachinery• Characterizing flow field through these devices using uPIV• Integrating micropatterned proteins into microfluidic devices• Performing blood flow experiments in microfluidic devices• Use of a CO2 Epilog Fusion Laser to make various cuts in a 5 mm thick acrylic• Variation of power, speed, and frequency• Simulation of smooth microfluidic channels of 100 to 500 um thickness.• Creation of PDMS membranes using silanization• Use of blood flow perfusion assays to gauge effectiveness of cold bonded microfluidic devices

Golden, Co

• Solidification of comprehension through review of weak areas• Reframing of understanding of course

Bachelor'S Degree, Chemical And Biochemical Engineering

Activities and Societies: American Institute of Chemical Engineers, The Oredigger, Society of Woman Engineers, Kappa Alpha Theta

Leadership, Post-Graduate

Activities and Societies: Kappa Alpha Theta I was chosen as 1 of 33 women to participate in the young alumnae leadership program for Kappa.