Since its inception in 2014 by pioneering Bitcoin enthusiasts, Tether has not only launched the first 'stablecoin', USD?, but also expanded its horizons into Tether Data, Tether Power, Tether Edu, and more.
Our platforms and tokens lead in liquidity, stability, and innovation, setting the foundation for the future.
Tether is committed to the extraordinary, seeking out and nurturing technologies that push humankind forward.
Our vision encompasses all horizons of innovation, promising a legacy of progress and transformation.
Our team thrives on ambition, creativity, and resilience.
Together, we tackle challenges, drive technological advancements, and build solutions that democratize access to finance, education, data, and technology for individuals, businesses, and governments around the globe.
Tether is seeking an experienced and visionary Head of Regulatory Affairs to design and execute global regulatory strategies for our Tether Evo business vertical.
If you have expertise in medical technology regulation, including pre-market approval processes, clinical trial oversight, and interaction with regulatory bodies both in the US and internationally, we want to hear from you.
What you'll doRegulatory Strategy Development: Leading the development and execution of regulatory strategies, identifying preferable markets from which to operate, and ensuring the company's readiness for compliance with relevant national and international regulations, with a focus on enabling market access for the company in the Brain-Computer Interface (BCI) space.Regulatory Advocacy and Thought Leadership: Leading or participating in regulatory agency interactions.
Engaging with relevant regulatory authorities, industry bodies, collaborative communities, and policymakers to shape the regulatory landscape for biotech, advocating for policies that promote innovation while ensuring patient safety.Policy Analysis and Guidance: Provide analysis on global regulatory policies and advise executive leadership on potential regulatory risks and opportunities, while driving initiatives to influence regulatory frameworks and monitoring for change across regulations to ensure proactive compliance.Product Development: Provide premarket regulatory strategy guidance as part of the product and product development processes to comply with regulatory requirements for early feasibility, first-in-human, investigational use, and clinical trials across multiple jurisdictions.
This includes advising on risk assessments, biocompatibility, and safety evaluations for Class 2a/2b and Class 3 active implantable medical devices, as well as the compilation of submission dossiers and management of breakthrough, TAP, and other available regulatory acceleration programs.Regulatory Approval Process: Oversee regulatory approval processes, including US FDA pre-market approval (PMA) and 510(k) submissions, and manage relationships with national regulators and policymakers in alternative and frontier markets.
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