Wade Munsch Email & Phone Number

Houston, Texas, United States

As 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.

Houston, Texas Area

Regulatory 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.

Austin, Texas Area

In 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.

Austin, Texas Area

Responsible 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.

In 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.

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 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.

Assisted 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.