Remote Head of Regulatory Affairs - Tether Evo; Fully Remote

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.

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.

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.

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.

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.

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.

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.

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.

• Minimum of 10 years regulatory experience in medical technology regulation, with a strong background in neurotechnology and implantable devices (Class 2a and 2b or Class
  3).

• Proven ability to interact effectively with US and international regulators,…