Head of Regulatory Affairs - Tether Evo (Fully Remote, Worldwide)

Tether Operations Limited; Canada; Remote; CAD 90,000 - 150,000; Full time

Job summary

An innovative firm is seeking a visionary Head of Regulatory Affairs to lead global regulatory strategies for their cutting-edge Tether Evo business vertical. This role demands expertise in medical technology regulation, particularly in neurotechnology and implantable devices. As a key player, you will oversee regulatory approval processes, advocate for policies that promote innovation, and collaborate with cross-functional teams to ensure compliance. If you are passionate about driving advancements in healthcare technology and have a proven track record in regulatory affairs, this is an exciting opportunity to make a significant impact in a forward-thinking organization.

Benefits

Flexible working hours

Health insurance

Professional development opportunities

Remote work options

Qualifications

• 10+ years of regulatory experience in medical technology, especially neurotechnology.
• Proven ability to navigate FDA and international regulatory landscapes.

Responsibilities

• Lead development of regulatory strategies for Tether Evo's BCI initiatives.
• Engage with regulatory authorities to shape policies that foster innovation.

Skills

Regulatory Strategy Development

Medical Technology Regulation

Clinical Trials Oversight

FDA Interaction

Neurotechnology Knowledge

Regulatory Document Preparation

Public Speaking

Team Collaboration

Bilingual (Spanish)

Education

Bachelor's Degree in a relevant field

Advanced Degree (Master's or PhD)

Tools

Regulatory Submission Software

Project Management Tools

Job description

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 humankind 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 and 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.

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.

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 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.