Strength • 8 years of regulatory and quality assurance & control experience in both government and industry settings • 6 years of military service in the U.S. Army • Experience and Familiar with regulatory submittals • Established knowledge of quality management • Excellent communication (written and oral) skills • Ability to travel, domestic and abroad • Proven successful track record of Premarket Notification [510(k)] • Regulatory Training Specialties: • Premarket Notification 510(k), Premarket Approval (PMA), and Medical Device Reporting (MDR) submission • Unique Device Identification (UDI) • Health Canada Medical Device Regulation • EU Technical File, Design Dossier, and Change Notification • China Food and Drug Administration (CFDA) • State License for Wholesale Distributor of Legend Drugs and Medical Devices Product Experience: • Anesthesiology Devices • Gastroenterology/Urology Devices • General Hospital Devices • General & Plastic Surgery Devices • Orthopedic Devices • Physical Medicine Devices

Regulatory Affairs Manager (Pre-market) @ • Develop the regulatory strategy for new products and ensure that modifications to existing products are in compliance with U.S. and Canadian regulations • Submit 510(k) application to the FDA and participate in the engineering change control process to provide guidance regarding engineering changes • Participate in review of user manuals, marketing literature and other product labeling to evaluate potential regulatory impact • Develop and maintain documented regulatory procedures as required to assure consistent and compliant regulatory activities • Lead yearly project to review FURLS establishment and product listings for all Invacare facilities, including subsidiaries, to ensure all information is correct • Review all Medical Device Establishment Licenses (MDELs) for all Invacare sites and submit to Health Canada yearly • Review advertising, marketing, and promotional materials to ensure that any regulatory and legal issues are addressed • Unique Device Identifier (UDI) Corporate RAQA Lead • State License for Wholesale Distributor of Legend Drugs and Medical Devices From June 2015 to Present (7 months) Senior Regulatory Affairs Specialist @ Regulatory Affairs Responsibilities: • Participate on product development teams to ensure US and other international regulatory requirements are incorporated as part of the development process. • Ensure compliance to all US, EU and ISO international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices. • Review human cells, tissues and cellular and tissue-based products (HCT/Ps). UDI Responsibilities: • Unique Device Identifier (UDI) RAQA Divisional Track-lead for Trauma & Extremities. • Represented Stryker Corporation at the AdvaMed UDI Orthopedic Kit Working Group meeting with the FDA at the Center for Devices and Radiological Health in Silver Spring, MD • Manage all Trauma & Extremities implants and instruments for UDI requirements; identify RAQA data attributes required for GUDID, support UDI Program activities across the division, and develop and implement UDI related processes at a division level. Labeling & Marketing: • Ensure that advertising, marketing, and promotional materials present information in a fair and balanced manner, with adequate provision for risk information. From March 2015 to May 2015 (3 months) Regulatory Affairs Specialist @ Achievements: • Authored ten (10) Premarket Notification [510(k)] submissions, two (2) Pre-Submissions for 510(k), and Annual Registration • Represented Stryker Corporation at the AdvaMed UDI Orthopedic Kit Working Group meeting with the FDA at the Center for Devices and Radiological Health in Silver Spring, MD From January 2013 to March 2015 (2 years 3 months) Youth Director @ • Teach the youth the basic tenets of the Christian faith and how to apply fundamental Christian values to life situations. • Help the youth establish Biblical guidelines for appropriate behavior and to model high standards and set a good example in the areas of relationships, commitment, follow thru and responsible living; • Recruit and train adult leaders to help in all areas of youth ministry; • Foster networking among local churches; • Counsel parents and students in crisis situations; and • Work closely with the Pastorate and Board of Trustees staff to further the mission of the church • Mentor youth in developing their leadership skills • Serve as a liaison between the church and other community organizations, people, and resources that relate to youth and youth ministries • Keep records of youth participation and manage the youth ministry budget • Support and guide the work of the Youth Ministry in an annual process of evaluating the vision and goals of the youth ministry and directing monthly planning sessions From November 2011 to March 2014 (2 years 5 months) President @ Core Services: • Provide strategy development, analysis and recommendations to individuals and organizations in a wide variety of regulatory affairs issues. Areas of Expertise: • FDA regulated devices and combination products, including in-depth knowledge and understanding of FDA expectations, requirements and regulations for device submissions; preparation and/or review of device submissions including 510(k), and PMA; device and combination product development issues, including preclinical data requirements, device regulatory strategy development, labeling, advertising and promotion; EU CE Mark Medical Device Directive (MDD, IVDD and AIMDD), EU Technical File and Design Dossiers, and Change Notification to EU Notified Body; ISO Standards for Class I, II, and III medical devices From November 2012 to February 2014 (1 year 4 months) Regulatory Specialist @ Regulatory Submissions: • Authored one (1) Premarket Notification [510(k)] submission, updated five (5) EU Technical Files, two (2) Design Dossiers, Annual Registration and Medical Device Listing Strategy, Quality & Implementation: • Represent Regulatory Affairs on assigned project teams through all phases of product development; communicate regulatory requirements and the impact of regulations to the development team. Design Control/ Labeling & Marketing: • Participate in new product development teams to ensure that quality and regulatory requirements are met during the development process. • Supports activities related to product labeling including providing guidance on requirements, coordination of activities, and change management. From February 2012 to December 2012 (11 months) Medical Device Staff Fellow @ Responsibilities: • Reviewed 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and Medical Device Reporting (MDR) submission. • Helped 510(k) reviewers at CDRH developed a checklist when reviewing 510(k)s for reusable medical devices. • Provided regulatory support and assistance for reviewers on regulatory submissions and files for Class I, II and III medical devices Achievements: • Facilitated the writing of the FDA 2011 Draft Guidance Document on processing and reprocessing of medical devices in health care settings. • Developed and presented a technical report on guidelines and standards on how to reprocess reusable medical devices to staffs of the Center for Devices and Radiological Health (CDRH) From July 2011 to September 2011 (3 months) Research & Development Quality Control Chemist @ •Ensured and reviewed regulatory documents and supervised regulatory files •Ensured that regulatory submissions were completed and in compliance with FDA Standards •Helped regulatory team observe applicable laws, regulations and guidance documents •Coordinated international regulatory standards and performed regulatory research From May 2009 to July 2010 (1 year 3 months) Quality Assurance Technician @ •Assisted in creating and implementing regulatory plans •Internal auditing and finding faults in products •Helped with product development and provided regulatory strategy •Worked closely with Regulatory Affairs Manager From January 2007 to May 2009 (2 years 5 months) Caucus goers @ Caucus for the Democratic Party in Mason City, IA. From 2007 to 2008 (1 year) Quality Control Chemist @ • Analyzed raw materials and finished products, using analytical chemistry techniques, ensured that clinical sites had needed tools and equipment for clinical trials and provided investigative support for successful product development From September 2003 to December 2006 (3 years 4 months)

Master of Science (M.Sc.), Regulatory Science, Graduate Student @ University of St. Thomas From 2012 to 2013 Post-Baccalaureate, Medical Device Development @ University of St. Thomas From 2012 to 2012 MSc, Regulatory Affairs and Services @ St. Cloud State University From 2010 to 2011 Bachelor of Science, Human Biology @ Minnesota State University, Mankato From 2007 to 2009 Elijah Wreh is skilled in: Post Market Surveillance, Medical Devices, Regulatory Science, FDA, Regulatory Affairs, ISO 13485, CAPA, Regulatory Submissions, CE marking, Clinical Trials, GLP, GMP, Biotechnology, Regulatory Requirements, Quality System