Head of Regulatory Affairs
hace 1 semana
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 the
human kind 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 market/s from which to operate, and to ensure 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 as well as 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,
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 policy-makers 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 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.
FDA, EMA Global Health Authority, ICH guidelines) both strategically and operationally and
provide direction to resolve complex regulatory issues.
frontier / alternative markets such as Latin America as part of developing equivalent clinical
or pre-clinical trials in other jurisdictions globally.
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 in
-
Head of Regulatory Affairs
hace 2 semanas
Granada, México Tether Operations Limited A tiempo completoSince 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...
-
Especialista Sr de Asuntos Regulatorios
hace 6 meses
Granada, México Cardinal Health A tiempo completo**_What Regulatory Affairs contributes to Cardinal Health_** **_ Accountabilities in this role_** - Prepare, assemble and submit regulatory submissions, dossiers and other Cofepris regulatory submissions. - Provide input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submissions...
-
Head of Media Investment
hace 6 meses
Granada, México Mindshare A tiempo completo**_Mindshare Head of Investment_** - Como Head of Investment, trabajarás en estrecha colaboración con el mercado local para realizar un seguimiento del rendimiento de las compras y optimizar la entrega de valor al negocio del cliente, además de brindarles a nuestros clientes información y contexto comercial de forma continua._ - Deberás trabajar de...
-
Medical Manager
hace 4 semanas
Granada, México Ipsen Mexico S de RL de CV A tiempo completoDevelopment and Execution of Medical Affairs activities and scientific projects based on the medical strategy and Plan of Action, in close collaboration with other global medical team members. Participation in planning and development of the local Medical Affairs plan in the Therapeutic Area (Neurology and Rare Diseases). - Act as the Medical Lead within the...
-
Gerente Asuntos Regulatorios
hace 6 meses
Granada, México Nestle Operational Services Worldwide SA A tiempo completo**Regulatory & Scientific Affairs Jr Manager** CMDX Main mission as a **RSA Manager for Nestlé Mexico **is to ensure functional leadership both internally and externally on specific regulatory topics through the development of Group’s positions and policies. You will also represent Nestlé in influencing activities with national authorities under the...
-
Head of Marketing
hace 3 meses
Granada, México Nestle Operational Services Worldwide SA A tiempo completoLugar de trabajo: Oficina Central Negocio: Ready to Drink (RTD) Esquema de trabajo: Híbrido (Se necesita estar de manera presencial en CDMX) **Propósito de la posición** Ser el ejecutor de la estrategia e identificando nuevas oportunidades de negocio. Enfocándose en las innovaciones. **¿Qué harás en tu día a día?** - Desarrollar el plan de...
-
Head of Program and Transactional Business Sd
hace 6 meses
Granada, México Siemens Energy A tiempo completo**A Snapshot of Your Day** The Program and Transactional Business Manager is responsible for the LTP and PDM supporting the region's open market in SD. Primarily responsible for processes such as LOA, market level pricing, competitiveness, regional strategy, business initiatives, technical offerings, etc., supporting the regional sales and marketing team to...
-
Field Access Manager
hace 6 meses
Granada, México Ipsen Mexico S de RL de CV A tiempo completoAt Ipsen we share a strong sense of purpose: to prolong patients’ lives, improve health outcomes and create a positive impact for patients and society. This deeply rooted purpose is at the heart of what we do, as we operate in highly specialized areas of healthcare: oncology, rare diseases and neuroscience. If you want to be part of a team who is...
-
Medical Excellence Coordinator
hace 6 meses
Granada, México Ipsen Mexico S de RL de CV A tiempo completoAt Ipsen we share a strong sense of purpose: to prolong patients’ lives, improve health outcomes and create a positive impact for patients and society. This deeply rooted purpose is at the heart of what we do, as we operate in highly specialized areas of healthcare: oncology, rare diseases and neuroscience. It is also an exciting time at Ipsen. We are on...
-
Msl Oncology
hace 6 meses
Granada, México Ipsen Mexico S de RL de CV A tiempo completoAt Ipsen we share a strong sense of purpose: to prolong patients’ lives, improve health outcomes and create a positive impact for patients and society. This deeply rooted purpose is at the heart of what we do, as we operate in highly specialized areas of healthcare: oncology, rare diseases and neuroscience. It is also an exciting time at Ipsen. We are on...
-
IT Risk
hace 3 semanas
Granada, México Nestlé A tiempo completo**About IT in Nestlé** We are a team of IT professionals from many countries and diverse backgrounds, each with unique missions and challenges in the biggest health, nutrition and wellness company of the world. We innovate every day through forward-looking technologies to create opportunities for Nestlé’s digital challenges with our consumers, customers...
-
Senior Risk
hace 6 meses
Granada, México Nestle Operational Services Worldwide SA A tiempo completo**About IT In Nestlé** We are a team of IT professionals from many countries and diverse backgrounds, each with unique missions and challenges in the biggest health, nutrition and wellness company of the world. We innovate every day through forward-looking technologies to create opportunities for Nestlé’s digital challenges with our consumers, customers...
-
Coordinador Comunicacion Digital
hace 8 meses
Granada, México Nestle Operational Services Worldwide SA A tiempo completo**Main Purpose**: Reports directly to the Nestle Communication Sr. Manager, dotted to the Nescafe Dolce Gusto Marketing Head; coordinate the strategy for all communications narratives ensuring that we consistently articulate NDG’s mission and vision and will be working closely with the community Manager as part of the team Responasabilities: - Provides...
-
Director, Business Cybersecurity Office
hace 6 meses
Granada, México Warner Bros. Discovery A tiempo completo**_Every great story has a new beginning, and yours starts here._** **_ Welcome to Warner Bros. Discoverythe stuff dreams are made of._** **Who We Are ** When we say, “the stuff dreams are made of,” we’re not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD’s vast portfolio of...
-
Cyber Security Senior Specialist
hace 6 meses
Granada, México Nestle Operational Services Worldwide SA A tiempo completo**About IT in Nestlé** We are a team of IT professionals from many countries and diverse backgrounds, each with unique missions and challenges in the biggest health, nutrition and wellness company of the world. We innovate every day through forward-looking technologies to create opportunities for Nestlé’s digital challenges with our consumers, customers...
-
Senior Portfolio Specialist
hace 6 meses
Granada, México Nestle Operational Services Worldwide SA A tiempo completo**About IT in Nestlé** We are a team of IT professionals from many countries and diverse backgrounds, each with unique missions and challenges in the biggest health, nutrition and wellness company of the world. We innovate every day through forward-looking technologies to create opportunities for Nestlé’s digital challenges with our consumers, customers...
-
Compliance Risk Assessment and Internal Testing
hace 1 semana
Granada, México Tether Operations Limited A tiempo completoCreated in 2014 by pioneering Bitcoin enthusiasts, Tether USDt was the first stablecoin in existence. Tether is disrupting the legacy financial system by offering a more modern approach to money. Our platforms and tokens lead in liquidity, stability, and innovation, setting the foundation for the future, and we make a significant contribution to a more...
-
Auditor Internacional
hace 6 meses
Granada, México Nestle Operational Services Worldwide SA A tiempo completo**Position Snapshot** Location: Mexico City Company: Marcas Nestlé S.A. de C.V. Act. Rate: Full-Time (100%) **Local influence, international opportunity, global impact: A fast-track career at Nestlé!** Nestlé Internal Audit (NIA) offers talented professionals the opportunity to join a diverse global team and to develop strong leadership skills with...
-
IT Project Manager
hace 4 meses
Granada, México Nestle Operational Services Worldwide SA A tiempo completo**About IT in Nestlé** We are a team of IT professionals from many countries and diverse backgrounds, each with unique missions and challenges in the biggest health, nutrition and wellness company of the world. We innovate every day through forward-looking technologies to create opportunities for Nestlé’s digital challenges with our consumers, customers...
-
International Operational Auditor
hace 6 meses
Granada, México Nestle Operational Services Worldwide SA A tiempo completoProducts and brands that everyone knows. An international working environment that inspires. A career that picks up speed in a global corporation. More than 300,000 employees worldwide are committed to great brands such as: MAGGI, KitKat, Nescafé Dolce Gusto, San Pellegrino or Purina. A dynamic, diverse international working environment, providing a genuine...