Head of Regulatory Affairs - Tether Evo (Fully
Tether Operations Limited
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, TetherEdu, and more. Our platforms and tokens lead in liquidity, stability, and innovation, setting the foundation for the future. Tether is committed to extraordinary technology and building solutions that democratize access to finance, education, data and technology for individuals, businesses and governments around the globe.
What you’ll do
* Regulatory Strategy Development: Leading the development and execution of regulatory strategies, identifying preferable markets, and ensuring the company’s readiness for compliance with relevant national and international regulations, with a focus on enabling market access in the Brain‑Computer Interface (BCI) space.
* Regulatory Advocacy and Thought Leadership: Leading or participating in regulatory agency interactions, engaging with authorities, industry bodies, collaborative communities, and policymakers to shape the regulatory landscape for biotech and advocating for policies that promote innovation while ensuring patient safety.
* Policy Analysis and Guidance: Providing analysis of global regulatory policies, advising executive leadership on potential regulatory risks and opportunities, and driving initiatives to influence regulatory frameworks while monitoring changes to ensure proactive compliance.
* Product Development: Providing pre‑market regulatory strategy guidance as part of product and development processes to comply with regulatory requirements for early feasibility, first‑in‑human, investigational use, and clinical trials across multiple jurisdictions. Includes advising on risk assessments, biocompatibility and safety evaluations for Class 2a/2b and Class 3 active implantable medical devices, and compiling submission dossiers and managing breakthrough, TAP, and other acceleration programs.
* Regulatory Approval Process: Overseeing regulatory approval processes, including US FDA pre‑market approval (PMA) and 510(k) submissions, and managing relationships with national regulators and policymakers in alternative and frontier markets.
* Cross‑functional Leadership: Collaborating with internal teams (e.g., R&D, legal, compliance) and partners to ensure alignment with regulatory requirements and 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.
Qualifications
* 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, including the FDA.
* Experience with PMA processes, 510(k) submissions, and clinical trials.
* Experience in successfully completing De Novo Classification Requests.
* Knowledge of FDA, EMA, Global Health Authority, ICH guidelines, and strategic and operational regulatory frameworks.
* Experience developing clinical or pre‑clinical trials in frontier or alternative markets such as Latin America.
* Expertise in preparing complex regulatory documents and major submissions, including scientific advice and approvals for clinical trials.
* Exceptional communication skills, both written and verbal, with experience in public speaking and representing companies in regulatory discussions.
* Strong team player, fully engaged with key stakeholders both within Tether and with partners, and capable of working collaboratively.
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