Remote Head of Regulatory Affairs

Summary

Join a pioneering team at Tether as we seek an experienced Head of Regulatory Affairs to design and execute global regulatory strategies for our Tether Evo business vertical.

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
• Added to the above, a 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
• Communication: 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

• 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
• 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
• 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