Home Delivery Perú | Head of Regulatory Affairs

hace 6 días

remoto, Perú Home Delivery Perú A tiempo completo
Head of Regulatory Affairs - Tether Evo (Fully Remote, Worldwide)

Tether Operations Limited

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 humanity 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. 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 changes across regulations to ensure proactive compliance.
  • Product Development: Provide premarket regulatory strategy guidance as part of the 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.
  • 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, particularly 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, willing to be fully engaged with key stakeholders both in Tether and with our partners. Must have hands-on professionalism capable 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 other relevant fields.
#J-18808-Ljbffr

  • Director of Regulatory Affairs and Compliance

    hace 5 días

    remoto, Perú Home Delivery Perú A tiempo completo

    At Home Delivery Perú, we are seeking an experienced and visionary leader to head our regulatory affairs department. The Director of Regulatory Affairs and Compliance will be responsible for designing and executing global regulatory strategies that align with our company's goals and objectives.About the Role:The ideal candidate will have a strong background...

  • Regulatory Affairs Director

    hace 4 días

    remoto, Perú Home Delivery Perú A tiempo completo

    About UsTether Operations Limited is committed to pushing the boundaries of innovation and making a positive impact on the world. We're a leader in the field of stablecoins and digital assets, dedicated to democratizing access to finance, education, data, and technology for individuals, businesses, and governments worldwide.As part of our vision to create a...

  • Head of Regulatory Strategy

    hace 4 días

    remoto, Perú Home Delivery Perú A tiempo completo

    Job Description:We are seeking an experienced Head of Regulatory Affairs to join our team at Tether Operations Limited. The successful candidate will be responsible for designing and executing global regulatory strategies for our Tether Evo business vertical.Key Responsibilities:Developing and implementing regulatory strategies to ensure compliance with...

  • Head of Global Regulatory Strategy

    hace 5 días

    remoto, Perú Home Delivery Perú A tiempo completo

    We are looking for a highly skilled and experienced professional to lead our global regulatory strategy efforts. As the Head of Global Regulatory Strategy, you will be responsible for developing and implementing regulatory strategies that drive business growth and ensure compliance with relevant regulations.About the Job:You will work closely with...

  • Regulatory Affairs Leader for Medical Technology Innovation

    hace 7 días

    remoto, Perú Home Delivery Perú A tiempo completo

    Head of Regulatory Affairs Job Description at Tether EvoOur company, Tether Operations Limited, is a pioneering force in the stablecoin and financial innovation space. Since its inception in 2014, we have not only launched the first 'stablecoin', USD₮, but also expanded our horizons into Tether Data, Tether Power, Tether Edu, and more. Our platforms and...

  • Global Compliance Lead

    hace 3 días

    remoto, Perú Home Delivery Perú A tiempo completo

    Job Summary:We're seeking an accomplished Head of Regulatory Affairs to spearhead regulatory strategy and compliance for Tether Evo. This is an outstanding opportunity to join a forward-thinking organization and contribute to shaping the future of the industry.Key Responsibilities:Develop and implement robust regulatory strategies to ensure compliance with...

  • Regulatory Affairs Strategist

    hace 5 días

    remoto, Perú Tether Operations Limited A tiempo completo

    About Tether Operations LimitedTether Operations Limited is a pioneering company in the field of digital assets, established to provide innovative solutions and drive technological advancements. Our team thrives on ambition, creativity, and resilience, working together to tackle challenges and build solutions that democratize access to finance, education,...

  • Regulatory Affairs Strategist

    hace 7 días

    remoto, Perú Tether Operations Limited A tiempo completo

    Tether Operations Limited is a pioneering company that has been at the forefront of innovation since its inception. Our commitment to pushing the boundaries of technology and finance has led to the development of cutting-edge platforms and tokens that set the foundation for the future.As a visionary leader, we are seeking an experienced Head of Regulatory...

  • Head of Regulatory Compliance

    hace 3 días

    remoto, Perú Tether Operations Limited A tiempo completo

    We are seeking a seasoned Head of Regulatory Compliance to join our team at Tether Operations Limited. The successful candidate will have a strong background in medical technology regulation and be responsible for leading the development and execution of global regulatory strategies.Key Responsibilities:Develop and execute regulatory strategies to ensure...

  • Regulatory Affairs Director

    hace 4 días

    remoto, Perú Tether Operations Limited A tiempo completo

    Tether Operations Limited is seeking an experienced and visionary Regulatory Affairs Director to lead the development and execution of global regulatory strategies for our Tether Evo business vertical. The ideal candidate will have a strong background in medical technology regulation, including pre-market approval processes, clinical trial oversight, and...

  • Head of Regulatory Affairs

    hace 5 días

    remoto, Perú Tether Operations Limited A tiempo completo

    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,...

  • Regulatory Affairs Director for Neurotechnology Innovation

    hace 5 días

    remoto, Perú Tether Operations Limited A tiempo completo

    Tether Operations Limited is committed to pushing the boundaries of innovation and technology. We are seeking a visionary Regulatory Affairs Director to lead our neurotechnology initiatives, driving strategic regulatory strategies that enable market access in this exciting field.The ideal candidate will have extensive experience in medical technology...

  • Regulatory Affairs Visionary

    hace 6 días

    remoto, Perú Home Delivery Perú A tiempo completo

    Company OverviewTether Operations Limited is a pioneering organization that has revolutionized the financial industry since its inception in 2014. With a strong commitment to innovation and progress, we have expanded our horizons into various platforms and tokens, setting the foundation for a brighter future.

  • Global Regulatory Lead

    hace 4 días

    remoto, Perú Tether Operations Limited A tiempo completo

    Tether Operations Limited is looking for a highly skilled Global Regulatory Lead to drive the company's regulatory strategy and ensure compliance with relevant national and international regulations. The successful candidate will have a strong background in medical technology regulation and be able to develop and execute effective regulatory...

  • Global Compliance Leader

    hace 5 días

    remoto, Perú Tether Operations Limited A tiempo completo

    About Tether Operations LimitedTether Operations Limited is a leading provider of innovative solutions and services, driving technological advancements and pushing the boundaries of what is possible. Our team is passionate about making a difference and creating value through collaboration, creativity, and innovation.Job OverviewHead of Regulatory Affairs -...

  • Delivery Manager

    hace 5 días

    remoto, Perú FullStack Labs Inc. A tiempo completo

    FullStack is the fastest-growing software consultancy in the Americas. We help organizations like Uber, GoDaddy, MGM, Siemens, and Stanford University build distributed software development teams, and deliver transformational digital solutions. As an employee-first company, we focus on hiring the most talented software designers and developers in the western...

  • Active Fun Diversion Peru SAC | Work From Home Lead Generation Analyst

    hace 2 semanas

    remoto, Perú Active Fun Diversion Peru SAC A tiempo completo

    Work From Home Lead Generation Analyst / Ref. 0244 talent.com At BairesDev, we’ve been leading the way in technology projects for over 15 years. We deliver cutting-edge solutions to giants like Google and the most innovative startups in Silicon Valley. Our diverse 4,000+ team, composed of the world’s Top 1% of tech talent, works remotely on roles that...

  • Active Fun Diversion Peru SAC | Work From Home Java Tech Lead

    hace 2 semanas

    remoto, Perú Active Fun Diversion Peru SAC A tiempo completo

    Work From Home Java Tech Lead / Ref. 0003 talent.com At BairesDev, we've been leading the way in technology projects for over 15 years. We deliver cutting-edge solutions to giants like Google and the most innovative startups in Silicon Valley. Our diverse 4,000+ team, composed of the world's Top 1% of tech talent, works remotely on roles that drive...

  • Software Delivery Coordinator

    hace 3 días

    remoto, Perú FullStack Labs Inc. A tiempo completo

    Key ResponsibilitiesPlan and execute software deployments with Tiger Teams to customersCollaborate with cross-functional teams to ensure smooth releasesDevelop and maintain release plans, schedules, and resource allocationAnalyze deployment metrics to identify areas for improvementRequirements4+ years of experience in release management or a similar...

  • Full Stack Engineering Project Manager

    hace 3 días

    remoto, Perú FullStack Labs Inc. A tiempo completo

    About the Role:We are seeking a highly skilled Technical Project Manager to join our team at FullStack Labs Inc. As a Technical Project Manager, you will be responsible for delivering high-quality software solutions to our clients.You will lead cross-functional teams to implement effective project management methodologies and tools to ensure timely delivery...