Ehab Esmail Email & Phone Number

Allen, Tx, Us

Lewisville, Tx, Us

Washington, District Of Columbia, Us

(Previous positions held; President 2018 - 2019, Vice President 2016 – 2018, Board Member 2009 – Present)

Leading company’s interaction with global regulatory authorities regarding product registrations, manufacturing, quality, preclinical, clinical, labeling, and compliance activities

Dallas, Tx, Us

Responsible for the development of policies, strategy, and programs including monitoring mechanisms to ensure regulatory affairs, regulatory compliance and related business activities comply with all global regulations. Supported all business units covering orthopedic surgical implants, bracing & supports, footcare, consumer products and recovery science (Bone growth stimulation, rehabilitation, pain management and healing)• Lead the corporate move from Vista California to Lewisville Texas• Successfully lead several Audits and any responses to audit findings; FDA (domestic and international), State of Texas, Notified Body, and various international government inspections• Lead the corporate wide implementation team of the European Medical Device Regulations (MDR) and Medical Device Single Audit Program (MDSAP) transition and EU Notified Body consolidation

Warsaw, Indiana, Us

Responsible for the development of policies, strategy, and programs including monitoring mechanisms to ensure pre and post-market regulatory, quality, clinical, and related business activities comply with all global regulations. • Global regulatory agencies; Device, Biologics, Pharma and BioPharma (CDRH, CDER, CBER, PMDA, ANVISA, CFDA, etc…)• Maintained relationships and interacted with global regulatory agencies and industry organizations on a proactive and independent basis• Worked with Executive Commercial leadership to identify key growth markets and lead teams in the development and execution of global regulatory strategies to bring new and modified products to the global markets • Global Clinical Trial Design and Implementation for Zimmer Biomet Biologics• Head of the Office Medical Affairs (Corporate): Call Center, Medical Education, and MSL• Lead a corporate wide implementation team for the European Medical Device Regulation (MDR) transition, Medical Device Single Audit Program (MDSAP) transition and EU Notified Body consolidation• Lead Global Teams with diverse backgrounds and areas of expertise to address global Regulatory, Clinical, Quality, and Medical needs of cross functional Business partners• Team development with diverse backgrounds and areas of expertise to address global Regulatory, Clinical and Quality needs of cross functional Business partners• Recruit, develop, manage and mentor the Regulatory, Scientific and Medical Affairs professionals. Foster employee career growth and development

Warsaw, Indiana, Us

Responsible for the development of policies, strategy, and programs including monitoring mechanisms to ensure pre and post-market regulatory, quality, clinical, and related business activities comply with all global regulations. • Key contributor to positive net sales growth• Global regulatory agencies; Device, Pharma and BioPharma (CDRH, CDER, CBER, PMDA, etc…) • Mapped Global Regulatory Pathways; Customized Global and Regional Execution• Global Clinical Trial Design and Implementation• Corporate oversight of PMA & Pharma Manufacturing and Quality System• Created a new Scientific and Medical Affairs Department (to address current needs in Clinical, Regulatory, Quality and Medical Affairs)• Created the Office of Medical Affairs: Call Center, Medical Education, and MSL• Team development with diverse backgrounds and areas of expertise to address global Regulatory, Clinical and Quality needs of cross functional Business partners

Warsaw, Indiana, Us

• Responsible for all global Clinical and Regulatory activities for Biomet Biologics and CITRA Labs • Responsible for corporate oversight and quality system management for all contract manufacturing for Biomet Biologics and CITRA Labs • Corporate responsibility for the Office of Medical Affairs -Medical Information Center (MIC) -Medical Education (Med Ed) -Medical Science Liaison (MSL)

Warsaw, Indiana, Us

• Responsible for all global Regulatory activities for Biomet SET and Biologics

Foothill Ranch, California, Us

Responsible for the development of policies, strategy, and programs including monitoring mechanisms to ensure pre and post-market regulatory, quality, clinical, and related business activities comply with all global regulations. • Key contributor to the 87 percent net sales growth for 2011• Directed all new business development activities to entry the Cone Beam 3D imaging market• Ensured compliance with all U.S. and international regulatory requirements pertaining to product approval, marketing, and labeling • Led the company’s interaction with Health Canada regarding product registrations of the all-tissue dental laser systems resulting in regulatory approval within one month of start date• Granted US approval to export all tissue dental lasers to Iran within four month of start date• Management Representative – Provided management with objective evaluation of quality performance and provide guidance for implementation of improvements, corrective and preventive actions related to processes that affect global Quality Assurance. • Ensured compliance to FDA 21 CFR Part 820 (GMP and Quality System Regulation), Europe (MDD 93/42/EEC and ISO 13485), and Health Canada Regulations (CMDCAS and ISO 13485) using risk based methodologies• Directed and implemented the re-engineering of effective Management Review, Design Control, Medical Device Reporting (MDR), Corrective and Preventive Action (CAPA) and Risk management processes, procedures and practices. • Closed 6 out of 10 CAPA’s within six month of start date• Ensured company practices are consistent with GCPs, FDA, ISO regulations and department SOPs.• Develop and implemented clinical studies for post-market surveillance, feasibility, marketing, and/or investigator initiated studies including setting and managing research agreement deliverables and aligning research goals in dental lasers and imaging.

Memphis, Tn, Us

Director, Sr. Manager, Manager, Sr. Regulatory Affairs Specialist (previous titles) Responsible for development and implementing corporate-wide best-practices for regulatory submissions, regulatory compliance and quality assurance activities world-wide. Regulatory representative in meetings with the US FDA (Pre-IDE, 100 day PMA, and 510(k) meetings), Health Canada, UK MHRA, BSI, TUV, KEMA and Brazil Health Surveillance Agency (ANVISA). Successfully supported worldwide launch of new products (Hips, Knees, Shoulders, Foot & Ankle, Small Joint Orthopedic and Biologics (Tissue containing Medical Devices)) through the development of well-thought regulatory strategies and timely regulatory submissions. Responsible for regulatory review and input on all corporate communications, product labeling, promotional materials, and corporate SOPs assuring compliance with applicable domestic and international government regulations. Directed and implemented the re-engineering of effective Management Review, Design Control, Medical Device Reporting (MDR), Corrective and Preventive Action (CAPA) and Risk management processes, procedures and practices. Hosted audits conducted by FDA, BSI, TUV, KEMA for the US (GMP and Quality System Regulation), Europe (MDD 93/42/EEC), and Canada (CMDCAS and EN ISO 13485:2003). Perform due diligence activities for potential acquisitions and lead post-acquisition integration. Serving as member of executive crisis management team.

Watford, Hertfordshire, Gb

Responsible for internal and external scientific interaction, direct project responsibility for FDA regulated and other clinical studies, assuring regulatory submissions and documentation comply with applicable domestic and international government regulations and company standards. Responsible for investigation, preparation, and submission of reports pursuant to Medical Device Reporting regulations. Developed and implemented a computer database to track product submissions and approvals. Responsible for the regulation of Internet and E-Commerce developments.

Watford, Hertfordshire, Gb

B.S., Mechanical Engineering

Executive Development Program For Senior Regulatory Professionals