Director, Quality Assurance/Regulatory Affairs/Clinical Affairs

• Aug 2020 - Present

MediView XR is an Ohio-based medical device company that has designed and patented intellectual property in development of extended reality surgical navigation with intended use in image guided procedures such as pleural effusions, venous access, and ablation and biopsy of cancerous tumors. MediView has partnered exclusively with the Lerner Research Institute at the Cleveland Clinic as a technology development partner. Through disruptive technology, MediView is redefining procedural guidance, navigation and teleprocedure.

Regulatory Affairs Management

• Feb 2019 - Aug 2020

Philips EPD Solutions is developing a disruptive technology which will improve the efficiency and efficacy of life-saving cardiac ablation procedures such as atrial fibrillation. EPD’s technology has the potential to address the key unmet need of real-time therapy assessment, which is one of the more significant limitations of the current standard of care. We aim to help to improve outcomes for millions of people and help maintain the rapidly rising cost of managing the disease. Philips EPD Solutions is developing a disruptive technology which will improve the efficiency and efficacy of life-saving cardiac ablation procedures such as atrial fibrillation. EPD’s technology has the potential to address the key unmet need of real-time therapy assessment, which is one of the more significant limitations of the current standard of care. We aim to help to improve outcomes for millions of people and help maintain the rapidly rising cost of managing the disease.

Senior Associate

• Jan 2018 - Feb 2019

I bring a wealth of industry knowledge as an experienced regulatory and quality professional with progressive experience in the medical device industry. My experience has afforded me a variety of roles within the industry including positions in regulatory affairs, regulatory compliance, regulatory intelligence, quality compliance, and quality management systems. I have developed strategies to bring organizations into compliance with the ISO 13485:2016 transition and the new EU Medical Device Regulations (MDR), have been instrumental in preparing organizations for their MDSAP inspections, and have led organizations through successful FDA inspections and Notified Body audits. Additionally, I have hands-on experience in developing global regulatory strategies for new products and have authored 510(k)s, design dossiers, and technical files in addition to supporting global registrations.

Regulatory Affairs Manager

• Apr 2016 - Jan 2018

• Develop regulatory strategies for Trauma and Deformity Correction, Sports Medicine, and Capital Equipment product lines. • Responsible for ensuring that global regulatory submissions, including US and EU, are appropriately developed for approval and clearance of orthopedic products and their respective accessories. These regulatory submissions can include, but are not limited to 510(k)s, Letters to File, Class I, Exempt Documentation, Technical Files, and Design Dossiers. • Responsible for regulatory intelligence including staying abreast of global regulatory requirements. Specifically, ensuring company-wide compliance to the recently published EU Medical Device Regulation by May 2020 and UDI requirements for FDA and EU. • Interact with regulators to resolve regulatory matters ranging from pending application negotiations and external audit findings. • Develop/maintain processes and procedures. • Member of the Complaint Review Board responsible for assessing the Trauma and Deformity Correction, Sports Medicine, and Capital Equipment complaints to determine next steps including the reporting of Adverse Events through the MDR process, EU Incident Reports, and any international countries reports per their regulations. • Initiate Medical Device Recalls and Field Safety Corrective Actions. This includes authoring the Initial Recall Reports, Follow-Up Reports, Final Reports, Health Hazard Evaluations, notifying the respective distributors, ensuring full-compliance from the field, and ensuring the FDA and EU Competent Authorities have the appropriate information as they request. • Member of the CAPA Review Team. • Responsible for developing regulatory strategies to enter new international markets including assessing distribution agreements to ensure compliance with applicable laws and regulations. • Lead external audits from regulatory bodies including FDA and BSi including announced and unannounced for quality system and regulatory files.

Global Regulatory Affairs Specialist - Sports Medicine

• Jun 2014 - Apr 2016

• Develop regulatory strategies for Sports Medicine Products. • Responsible for ensuring that global regulatory submissions, including US and EU, are appropriately developed for approval and clearance of orthopedic products and their respective accessories. These Regulatory submissions can include, but are not limited to Premarket Notifications 510(k)s, Technical Files, and Design Dossiers. • Ensure regulatory interface throughout the product realization process and during the entire product life cycle including post-market surveillance. • Develop internal documentation when formal FDA submissions are not required (LTF or memo-to-file). • Review and approve marketing literature and other items for internal and external dissemination. • Review and approve all Engineering Change Requests (ECRs). • Coordinate with International regulatory on submission timelines and the dissemination of information.

Lead Technical Recruiter

• Feb 2012 - Jun 2014

Lead Recruiter

• Oct 2010 - Feb 2012

Director of World Impact Youth Ministries

• Jan 2008 - Oct 2010