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    Trilo Das

    Advisor - Regulatory Strategies-Market Access

    Professional Background

    Trilo Das is a highly accomplished advisor with extensive experience in the healthcare and biotechnology sectors. Over the years, he has held pivotal roles in various organizations, ensuring the success of regulatory strategies and product lifecycle management globally. As an advisor for RAPS Texas and the Texas Health Catalyst at the Dell Medical School, University of Texas, his work incorporates vast expertise ranging from devices and combination products to digital healthcare innovations and artificial intelligence.

    Das has continually demonstrated his capability to lead global regulatory strategies across multiple regions, including the US, EU, China, Japan, and Latin America. He possesses a rich history of advising on critical matters such as EU MDR compliance, CE Marking, and FDA submissions, including pre-market approval (PMA) supplements and 510(k) submissions. His adept leadership as well as his engagement with project teams and subcommittees throughout the regulatory affairs landscape have been instrumental in shaping effective global clinical study strategies.

    In his career journey, Das has earned a reputation as an excellent collaborator, negotiator, and communicator. His approach emphasizes building strong relationships with regulatory agencies, contractors, and business partners, which has proven crucial for both compliance and commercial success.

    Education and Achievements

    Trilo Das kicked off his educational journey with a Bachelor of Architecture (B.Arch.) in Architectural Engineering from the prestigious College of Architecture, where he laid the groundwork for his analytical and design thinking skills. He further honed his expertise by studying Software Engineering and Information Technology at General Electric, which complemented his technical understanding of digital innovations.

    He expanded his international business acumen with a Post Graduate Diploma in International Business (PGDIFT) from the World Trade Center in Cuffe Parade, Bombay, India. Most notably, Das pursued a Master of Business Administration (MBA) specializing in Digital Innovation at Maastricht University, enhancing his leadership and strategic thinking in the rapidly evolving business landscape.

    Notable Contributions

    Trilo Das has also played vital roles in higher education and entrepreneurship as an advisor to top global consultancy firms and organizations such as Delta V at the Martin Trust Center for MIT Entrepreneurship. His involvement has empowered startups from ideation to venture capital funding, showcasing his commitment to fostering innovation and entrepreneurship.

    Furthermore, Das' previous roles include Vice President of Global Regulatory Affairs at Avania and Senior Regulatory Affairs Specialist at leading companies like Stryker and Johnson & Johnson. His alignment with startup ecosystems as an expert mentor at Derby Entrepreneurship Center at Tufts and as an advisor at the Texas Health Catalyst underlines his dedication to advancing early-stage companies with solid regulatory frameworks and market entry strategies.

    Conclusion

    Trilo Das continues to be a prominent figure in regulatory affairs, digital health innovation, and entrepreneurship. His broad skill set encompasses regulatory strategy development, clinical study advocacy, and life cycle management of healthcare products, making him a valuable asset to organizations looking to navigate the complexities of the global healthcare landscape. His professional journey is marked by a series of notable achievements and contributions, underscoring his commitment to enhancing the industry as a whole.

    Related Questions

    How did Trilo Das develop his expertise in global regulatory strategies within the biotech sector?
    What inspired Trilo Das to focus on digital healthcare innovations and artificial intelligence in his career?
    In what ways has Trilo Das contributed to the success of startups in navigating the regulatory landscape?
    How does Trilo Das leverage his educational background in architecture and software engineering in his role as an advisor?
    What are some of the key regulatory challenges Trilo Das has faced in the international markets he has worked in?
    How has Trilo Das's leadership experience shaped his approach to building teams in the regulatory affairs domain?
    What insights can Trilo Das share about the future of digital healthcare and regulatory compliance?
    Trilo Das
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    Location

    Sugar Land, Texas, United States