Head of Regulatory Affairs

Summary

Join Tether, a leader in stablecoin technology, as their Head of Regulatory Affairs for Tether Evo. This role requires a minimum of 10 years of experience in medical technology regulation, particularly in neurotechnology and implantable devices. You will lead the development and execution of global regulatory strategies, ensuring compliance with national and international regulations, particularly focusing on market access in the Brain-Computer Interface (BCI) space. Responsibilities include regulatory advocacy, policy analysis, product development guidance, overseeing approval processes, and cross-functional collaboration. The ideal candidate will possess strong communication skills and experience interacting with regulatory bodies like the FDA. This position offers the opportunity to shape the regulatory landscape for biotech and contribute to Tether's innovative work.

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 but also with our partners. Must have hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills

Responsibilities

• Lead the development and execution of regulatory strategies
• Identify preferable market/s from which to operate, and ensure the company’s readiness for compliance with relevant national and international regulations
• Focus on enabling market access for the company in the Brain-Computer Interface (BCI) space
• Lead or participate in regulatory agency interactions
• Engage 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
• Advise executive leadership on potential regulatory risks and opportunities
• Drive initiatives to influence regulatory frameworks
• Monitor 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
• Advise on risk assessments, biocompatibility and safety evaluations for Class 2a/2b and Class 3 active implantable medical devices
• Compile submission dossiers
• Manage breakthrough, TAP, and other available regulatory acceleration programs
• Oversee regulatory approval processes, including US FDA pre-market approval (PMA) and 510(k) submissions
• 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
• Advise on post-approval compliance and ensure ongoing adherence to regulatory requirements and continued market access, including post-market approval monitoring, safety reporting, and product modifications

Preferred Qualifications

• 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