Wade Munsch Email and Phone Number
Wade Munsch work email
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Wade Munsch personal email
Wade does not only love cooking and working on cars in his downtime. He is also the Director of Regulatory Affairs for Biotex and the Laboratory Manager for Criterion.Since starting his journey with Biotex in 2019 as the Regulatory Affairs Manager, Wade has become a significant force within the department. He continues to interface with clients directly and facilitates communication between development teams and regulatory agencies.Wade is responsible for updating and maintaining quality system policies and procedures to ensure products comply with FDA QSR, ISO 13485, EU MDR, and other regulations. He also conducts internal audits to ensure everyone complies with regulatory standards.Safety and quality have always been important to Wade, even when he had just started his career in Engineering. While attending college, he worked as a Tool Rental Associate at The Home Depot, helping customers learn how to use their tools and repairing their damaged equipment. After graduating from the University of Texas at San Antonio in 2009 with a degree in Electrical Engineering, he has held various roles in safety and compliance for different companies as a Product Safety Engineer.When he's not busy helping clients with safety and regulatory concerns, Wade focuses his energy on home improvement. He enjoys remodeling the home he shares with his wife, two kids, and three dogs.Being a foster parent is one of Wade's most important responsibilities, and he makes sure he nourishes his family with his awesome recipes and fabulous cooking. He also explores the outdoors in his spare time, testing his endurance by fishing, camping, hiking, and rock climbing.
Biotex Inc
View- Website:
- biotexmedical.com
- Employees:
- 29
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Director Of Regulatory Affairs (Biotex) / Laboratory Manager (Criterion)Biotex Inc Oct 2023 - PresentHouston, Texas, United StatesAs the Director of Regulatory Affairs, I am responsible for Biotex’s regulatory efforts and the regulatory department as follows:Technical/Problem Solving• Plan and direct all aspects of regulatory activities and projects within the organization.• Ensure all regulatory projects, initiatives, and processes are in conformance with companies established policies and objectives.• Develop department budgets, policies and procedures to support the functional infrastructure.Leadership• Develop long-term and strategic plans.• Negotiate critical and controversial issues with officers of other organizations and companies.• Directly supervise technical staff and play a major role in maintaining staff utilization.• Assign regulatory roles to incoming projects.Client Focus• Lead and develop highly complex and challenging client relationships.• Able to effectively challenge clients to make decisions in their best interest for the long term.• Remove barriers to teamwork and collaboration.• Model companies’ values of respect, integrity and fairness.Talent Development• Encourages constructive feedback and effectively addresses performance issues.• Allocate work responsibilities to foster employee development.• Provide effective coaching to staff to change behavior as needed.Influence and Selling• Drive digital marketing, including blog posts on company website and social media.Laboratory Manager for Criterion (Biotex's In-House Testing Lab)• Supervises lab operation.• Serves as the primary technical expert for standards interpretation. -
Regulatory Affairs Manager (Biotex) / Laboratory Manager (Criterion)Biotex Inc Feb 2019 - Oct 2023Houston, Texas AreaRegulatory Affairs Manager for Biotex• Handles day-to-day regulatory needs, including interaction with regulatory authorities for marking applications, clinical trials, and various other regulatory tasks.• Responsible for updating and maintaining quality system policies and procedures to ensure compliance with FDA, QSR, ISO 13485, EU MDR, and other regulations, including conducting internal and supplier audits to assure compliance with regulations.• Direct interface and facilitator between development teams and regulatory agencies.Laboratory Manager for Criterion (Biotex's In-House Testing Lab)• Supervises lab operation.• Serves as the primary technical expert for standards interpretation. -
Medical Technical Manager, Product SafetyEurofins E&E North America Dec 2013 - Feb 2019Austin, Texas AreaIn addition to previous responsibilities as a Product Safety Engineer:Responsible for staying abreast with medical safety requirements and sharing that knowledge with other engineers, sales staff, and customers as necessary. Providing medical quality related management to laboratory staff supporting quality of work and quantity of throughput for all MET locations engaged in medical product safety work. -
Product Safety EngineerEurofins E&E North America Dec 2012 - Dec 2013Austin, Texas AreaResponsible for setting up and executing tests, preparing reports on tests according to standards, and providing basic management to local laboratory staff.Preformed various product safety evaluations to a wide range of products and product standards (61010-1, 60825-1, 60335-1, and 60950-1) with a concentration on Medical Electrical Equipment (60601-1).Experience evaluating medical products to the third edition of IEC 60601-1 including the evaluation of risk assessments to ISO 14971. -
Lead Product Safety EngineerProfessional Testing Apr 2012 - Dec 2012In addition to previous responsibilities as a Product Safety Engineer:Responsible for ensuring staff was trained to perform the required evaluations/testing.Stayed abreast with changes in standards and defined the avenue for implementation of required changes.Performed formal annual performance appraisals for assigned engineers and technicians, as well as provided informal performance feedback.Ensured needed changes to quotes, schedules, etc. were communicated to the appropriate internal personnel.Performed technical reviews of Product Safety projects performed by others in the team. -
Product Safety EngineerProfessional Testing Jul 2009 - Apr 2012Preformed various product safety evaluations to a wide range of products and product standards (61010-1, 60825-1, 60335-1, and 60950-1) with a concentration on Medical Electrical Equipment (60601-1).Experience evaluating medical products to the third edition of IEC 60601-1 including the development and evaluation of risk assessments to ISO 14971.Selected to represent the product safety division of Professional Testing as a Technical Advocate for the purpose of generating accurate quotes and positive initial customer relations. -
Tool Rental AssociateThe Home Depot Sep 2005 - Jul 2009Assisted customers in findings the appropriate equipment for their projects.Educated customers on the proper use of each tool.Serviced and repaired damaged or broken equipment.
Wade Munsch Skills
Wade Munsch Education Details
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Electrical Engineering
Frequently Asked Questions about Wade Munsch
What company does Wade Munsch work for?
Wade Munsch works for Biotex Inc
What is Wade Munsch's role at the current company?
Wade Munsch's current role is Director of Regulatory Affairs (Biotex) / Laboratory Manager (Criterion) at Biotex Inc.
What is Wade Munsch's email address?
Wade Munsch's email address is wm****@****est.com
What schools did Wade Munsch attend?
Wade Munsch attended The University Of Texas At San Antonio.
What are some of Wade Munsch's interests?
Wade Munsch has interest in Lasers, Working With Electronics, Building And Repairing Computers, Participating In Various Sports.
What skills is Wade Munsch known for?
Wade Munsch has skills like Iec, Product Development, Product Safety, Test Equipment, Electronics, Testing, Troubleshooting, Engineering Management, Fcc, Electrical Engineering, Tests, Engineering.
Who are Wade Munsch's colleagues?
Wade Munsch's colleagues are Danny Preston, Amy Williamson, Matthew Fox, Yosef Kidane, Nasir Fazal, Kimberly Najjar, Arun Pillai.
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