Regulatory Affairs Strategist

hace 3 semanas

Lima, Perú Tether Operations Limited A tiempo completo

Tether Operations Limited

PEN 70,000 - 100,000 (estimated)

Company Overview: Tether is a pioneering company in the stablecoin and blockchain industry, committed to pushing the boundaries of innovation and technology.

About the Role: We are seeking an experienced Regulatory Affairs Strategist to design and execute global regulatory strategies for our biotech 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.

Key Responsibilities:

  • Leading the development and execution of regulatory strategies, identifying preferable market/s from which to operate, and ensuring the company's readiness for compliance with relevant national and international regulations.
  • Providing analysis on global regulatory policies, advising executive leadership on potential regulatory risks and opportunities, and driving initiatives to influence regulatory frameworks as well as monitoring for change across regulations to ensure proactive compliance.
  • Collaborating 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.

Requirements:

  • A 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, with successful completion of 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.
  • Expertise in preparing complex regulatory documents and other major regulatory submissions, including 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.

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.

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