Carolyn is a seasoned medical device executive with over 30 years of experience leading global regulatory, quality, and clinical initiatives. She has a proven track record of success in navigating complex regulatory landscapes and ensuring compliance with FDA, EU, and other international standards.

Before joining Nexalin, Carolyn held leadership roles at prominent organizations including Medtronic, Advanced Sterilization Products, and Smith & Nephew. She has spearheaded EU MDR compliance efforts, directed the preparation of numerous regulatory submissions (510(k), IDE, PMA, BLA), and effectively managed regulatory inspections and audits.

Carolyn is passionate about developing and implementing clinical strategies that align with business goals and regulatory requirements. She is a strong advocate for continuous improvement initiatives and has implemented effective post-market surveillance programs to monitor product performance and safety.

Carolyn is a key member of the Nexalin executive team and plays a vital role in ensuring the company’s products meet the highest standards of safety, efficacy, and compliance. Her expertise and leadership are instrumental in driving Nexalin’s mission to advance neuro health through innovative solutions.