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 the
human kind 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 do
Regulatory Strategy Development: Leading the development and execution of regulatory
strategies, identifying preferable market/s from which to operate, and to ensure the company’s
readiness for compliance with relevant national and international regulations. There should be 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 as well as 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,
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, as well as manage relationships with
national regulators and policy-makers in alternative and frontier markets.
Cross-functional Leadership: Collaborate with internal teams (e.g., R&D, legal, compliance) in
both Tether and with our partners to ensure alignment with regulatory requirements and to
proactively address emerging regulatory challenges in the biotech industry.
Regulatory Oversight: Advising on post-approval compliance and ensuring ongoing adherence
to regulatory requirements and continued market access, including post-market approval
monitoring, safety reporting, and product modifications.
