Remote Head of Regulatory Affairs

Summary

Join Tether as a visionary Head of Regulatory Affairs to design and execute global regulatory strategies for our Tether Evo business vertical. Develop regulatory strategies, lead regulatory agency interactions, provide policy analysis and guidance, and oversee product development and approval processes.

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
• Ability to apply knowledge of key regulatory frameworks in the U.S. and internationally (e.g. FDA, EMA Global Health Authority, ICH guidelines)
• Added to the above, a demonstrated ability and appetite to apply the above knowledge in frontier / alternative markets such as Latin America
• 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
• Exceptional communication skills, both written and verbal, with experience in public speaking and representing companies in regulatory discussions

Responsibilities

• Regulatory Strategy Development: Leading the development and execution of regulatory strategies
• Regulatory Advocacy and Thought Leadership: Leading or participating in regulatory agency interactions
• Policy Analysis and Guidance: Provide analysis on global regulatory policies, and advise executive leadership on potential regulatory risks and opportunities
• 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
• Regulatory approval process: Oversee regulatory approval processes, including US FDA pre-market approval (PMA) and 510(k) submissions
• 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

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