Head Of Regulatory Affairs

6 days ago

Salt Lake City, United States Tether Operations Limited Full time

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 markets from which to operate, and ensuring 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 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, 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 policymakers 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.

Minimum Requirements
  • 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.
  • Ability to apply knowledge of key regulatory frameworks in the U.S. and internationally (e.g. FDA, EMA Global Health Authority, ICH guidelines) both strategically and operationally and provide direction to resolve complex regulatory issues.
  • Demonstrated ability and appetite to apply the above knowledge in frontier / alternative markets such as Latin America as part of developing equivalent clinical or pre-clinical trials in other jurisdictions globally.
  • Experience across the process to obtain necessary approvals for applications and products, specifically for Class 2a/2b and Class 3 active implantable medical devices.
  • Expertise in preparing complex regulatory documents and other major regulatory submissions, including the preparation and execution of interactions with regulatory authorities, in particular for 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.
  • Must be a strong team player, and willing to be fully engaged with key stakeholders both in Tether and with our partners. Must have hands-on professional capability of working collaboratively and independently, with excellent verbal and written communication skills.
Additional Skills
  • Fluency in a second language is a plus, notably Spanish.
  • Experience working in smaller/startup companies, having an appreciation for their limitations and unique operating environments is highly desirable.
  • A strong scientific and technical background, ideally with experience in the medical technology space, including working knowledge of neurotechnology, gene therapies, or similar fields.
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