Regulatory Affairs Strategist for Neurotechnology Innovation

4 days ago

Old Toronto, Canada Tether Operations Limited Full time
Job Overview

We are seeking an experienced Regulatory Affairs Strategist to lead our global regulatory strategy for Tether Evo, a cutting-edge neurotechnology business vertical.

The ideal candidate will have a strong background in medical technology regulation, with expertise in neurotechnology and implantable devices (Class 2a and 2b or Class 3). They will be responsible for developing and executing regulatory strategies, interacting with US and international regulators, and ensuring compliance with relevant national and international regulations.

Key Responsibilities:
  • Develop and execute global regulatory strategies for Tether Evo, identifying preferable markets and ensuring readiness for compliance with relevant regulations.
  • Lead interactions with regulatory agencies, industry bodies, and policymakers to shape the regulatory landscape for biotech and advocate for policies that promote innovation while ensuring patient safety.
  • Analyze global regulatory policies and advise executive leadership on potential regulatory risks and opportunities, driving initiatives to influence regulatory frameworks and monitoring changes across regulations.
  • Provide premarket regulatory strategy guidance for product development processes, advising on risk assessments, biocompatibility, and safety evaluations for Class 2a/2b and Class 3 active implantable medical devices.
  • Oversee regulatory approval processes, including US FDA pre-market approval (PMA) and 510(k) submissions, and manage relationships with national regulators and policymakers in alternative and frontier markets.
Requirements:
  • Minimum of 10 years of regulatory experience in medical technology, 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, clinical trials, and De Novo Classification Requests.
  • Ability to apply knowledge of key regulatory frameworks strategically and operationally, providing direction to resolve complex regulatory issues.
  • Demonstrated ability to apply knowledge in frontier/alternative markets, such as Latin America, by developing equivalent clinical or pre-clinical trials in other jurisdictions globally.
  • Expertise in preparing complex regulatory documents and other major regulatory submissions, including interactions with regulatory authorities 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.
Additional Skills:
  • Fluency in a second language is a plus, notably Spanish.
  • Experience working in smaller/startup companies, with 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.

We offer a competitive salary range of CAD $125,000 - $150,000 per year, commensurate with experience.

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