SAN JUAN, PR, September 14, 2026 /24-7PressRelease/ -- Vivian L. Borrero, M.Ed., RAC (US & EU), has been recognized for 40 years of leadership and achievement in pharmaceutical and medical technology, distinguished by her work transforming regulatory and quality organizations, developing global capabilities, and advancing professional education across regulated industries.

As the founder and principal of Telestasis LLC since 2026, Ms. Borrero provides strategic advisory and professional education services in regulatory affairs, quality, governance and product development. Telestasis represents the evolution of an entrepreneurial and educational path she began decades earlier, bringing together her experience in industry transformation, organizational capability development and professional education. Her work is supported by the Telestasis Method™️, a proprietary framework she developed to guide organizations from understanding complex challenges through alignment and capability building to sustained performance. Telestasis is also home to the Global Product Development Academy, a mastery-based professional education platform integrating regulatory, quality, engineering, risk management and product development disciplines. With industry experience beginning at Johnson & Johnson Baby Products in 1986, Ms. Borrero has built expertise spanning regulatory affairs, quality management, risk management, corporate governance, product development and organizational transformation. Her career has extended across pharmaceutical, medical device and other regulated environments in U.S. and international markets. Among her accomplishments, she has led complex regulatory remediation efforts that successfully transitioned operations from FDA Official Action Indicated to No Action Indicated status and has led FDA inspections resulting in zero Form 483 observations.

From 2021 to 2025, Ms. Borrero served as Director, Regional Strategy & Operations – Global Regulatory Affairs at Johnson & Johnson Innovative Medicine, supporting regulatory execution across 179 countries and three international regions. Her leadership encompassed global planning, governance, performance monitoring, resource management and cross-functional integration.

Her earlier Johnson & Johnson MedTech leadership included serving as Director, Regulatory Affairs Strategy & Head of Transformation – Regulatory Affairs International Team from 2017 to 2021. She established and led a centralized regulatory operations model supporting 126 countries, introducing governance frameworks, standardized processes and performance systems that strengthened global execution and contributed to enterprise efficiencies. From 2015 to 2017, she held regulatory strategy and innovation leadership roles for Latin America, including responsibility for regulatory execution across 35 countries. Her work at Johnson & Johnson MedTech also encompassed mergers and acquisitions, regulatory and quality-system integration, and organizational transformation.

From 2010 to 2015, Ms. Borrero served as Associate Director, Quality Assurance & Compliance at Stryker's Latin America Campus in Puerto Rico, directing quality and compliance for multisite manufacturing operations serving global markets. Her responsibilities included FDA inspection leadership, mergers and acquisitions, quality-system integration and improvement, and the establishment of sustainable compliance capabilities. She also held senior quality and regulatory leadership responsibilities within the pharmaceutical industry, including at IVAX Pharmaceuticals.

Ms. Borrero's entrepreneurial work began decades earlier, first through the nonprofit Innovaciones Educativas Inc. and later through Quality Support Systems PR Inc. Through these organizations, she consulted with companies in Puerto Rico, the continental United States, the Dominican Republic, Brazil and Spain through 2010. Her work included professional education and talent development, new product development and introduction, audit and regulatory inspection management, quality-system design and implementation, and organizational transformation programs.

A significant part of this early work centered on helping industry respond to changing regulatory expectations. She supported implementation of FDA's Quality System Regulation and Design Control requirements in 1996 and 1998, respectively, developing and sustaining the Design Control & Validation Academy and an annual medical device industry conference in Puerto Rico. She led the conference for five consecutive years with participation from the U.S. Food and Drug Administration. The Design Control & Validation Academy later evolved into the Global Product Development Academy now housed within Telestasis.

Throughout her career, Ms. Borrero has worked, consulted and taught across cultures in English, Spanish and Portuguese. She considers developing others among her most meaningful accomplishments, and professionals she has led and mentored have advanced to senior leadership and executive positions, including vice president, senior director and chief executive officer roles.

Ms. Borrero earned a Master of Education in Education Management from Consejo Iberoamericano en Honor a la Calidad Educativa and a Bachelor of Science in Engineering from Century University. Her professional credentials include Regulatory Affairs Certification in the United States and European regulatory practice, maintained since 1994, as well as qualification as an ISO Lead Assessor through BSI.

Persistence and anticipation have been guiding principles throughout Ms. Borrero's four-decade career. By anticipating regulatory, organizational and industry change, she has consistently sought to move regulatory and quality organizations beyond reactive compliance, bringing greater structure, measurement and foresight to how organizations identify risk, make decisions and sustain performance.

Beyond her professional pursuits, Ms. Borrero is deeply engaged in faith and community service. She is a founding member and board member of SDF House of Worship, a Christian church based in Caguas, Puerto Rico, where she also serves in worship pastoral leadership. She serves as a consulting board member for Fundación Yo Prefiero Sonreír and for Conservatorio de Artes y Seminario Aletheia in Caguas, Puerto Rico. She is also part of the leadership team organizing and deploying Misión Más Uno, a recurring community outreach initiative that connects individuals and families with mental health resources, housing assistance, food and clothing through partnerships with municipalities, police departments, local churches and community organizations.

Her creative work extends to writing and music. Ms. Borrero is publishing The Divine Architecture of Empowerment, the first book in a planned series. As a member of the music group Unción Santa, she has released three albums: Vivianne: De Eternidad a Eternidad, Sol de Justicia and Creo en Ti. A songwriter, vocalist and musician, she wrote many of the songs featured on the recordings, and her compositions are registered with the U.S. Library of Congress.

Born in San Juan, Puerto Rico, Ms. Borrero is married with five children and four grandchildren. Family, faith, music, service and the development of others remain important dimensions of her life and work.

Looking ahead, Ms. Borrero aims to establish Telestasis as a globally recognized organization for regulatory, quality and governance advisory services and product development education. Central to that vision is the continued expansion of the Global Product Development Academy and the evolution of its mastery-based, tiered professional credentialing model. She also plans to continue writing The Divine Architecture of Empowerment series. Through these endeavors, she seeks to strengthen organizations, develop people and contribute to the next generation of global leaders.

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