Head of Regulatory Affairs

2 weeks ago

Montréal QC, Canada Tether Operations Limited Full time

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

  • Regulatory Affairs, Associate

    5 days ago

    Montréal, QC, Canada Euro-Pharm Full time

    Job Summary Working within Regulatory Affairs, reporting to Head, Regulatory Affairs, Associate, Quality & Regulatory Affairs is responsible for performing the required tasks related to Regulatory Affairs. Principal Responsibilities **Regulatory Affairs**: Coordinate with the Export department the regulatory and quality documents required for product...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Montréal, QC, Canada Beiersdorf Full time

    Sr. Analyst, Quality and Regulatory Affairs It all started with a pharmacist and a dream 140 years ago. Today, Beiersdorf is a global company with iconic brands — Coppertone, Aquaphor, Eucerin, Elastoplast and NIVEA — focused on providing innovative, clinically-proven and safe skin and sun care solutions to more than 500 million consumers in over 200...

  • Regulatory Affairs Specialist

    5 days ago

    Montréal, Canada Vision Group Full time

    **See if you are our next**: **BILLINGUAL REGULATORY AFFAIRS SPECIALIST (Operating Room Experience Required)** Working at Vision Group's head office is working for the North American leader in vision correction. It means being able to concretely contribute to the development of the company and support more than 12 brands and more than 70 clinics across...

  • Associate, Regulatory Affairs

    2 weeks ago

    Montréal, Canada Endo International Full time

    Job Description Summary At Paladin, we strive to offer a work environment that meets the diverse needs of our team members and advances the goals of the individual, the team and the company, while promoting flexibility, accountability and collaboration. If you're looking for a hybrid work environment, Paladin is the place for you! This position requires a...

  • Regulatory Affairs Associate

    19 hours ago

    Montréal, Canada Medisca Pharmaceutique Inc Full time

    **Medisca **is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding, **Medisca** is a...

  • Manager, Regulatory Affairs

    7 days ago

    Montréal, Canada G&L Scientific Inc. Full time

    **About us**: G&L Scientific is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions. As demand for our services and solutions continues to increase, we have an exciting new opportunity for a Manager,...

  • Manager, Regulatory Affairs

    1 week ago

    Montréal, Canada G&L Scientific Inc. Full time

    **About us**: G&L Scientific is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions. As demand for our services and solutions continues to increase, we have an exciting new opportunity for a Manager,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Montréal, Canada Amaris Consulting Full time

    **Who are we?**:**Amaris Consulting** est une société indépendante de conseil et de technologies au service des entreprises. Avec plus de 1000 clients dans le monde, nous déployons des solutions pour les plus grands projets depuis plus d'une décennie - tout ceci est rendu possible par une équipe internationale de 7 600 talents répartis sur les 5...

  • Regulatory Affairs Specialist

    2 weeks ago

    Montréal, Canada vitaltracer Full time

    Work Term: Permanent - Work Language: English - Hours: 38 to 44 hours per week - Education: Master's degree - Experience: 5 years or more - Bioengineering and biomedical engineering - Mechanical engineering **Tasks**: - Analyze and provide advice on the managerial methods and organization of an establishment - Develop quality management and quality...

  • Regulatory Affairs Expert

    9 hours ago

    Rivière-du-Loup, QC, Canada Amicus Search & Recruitment Full time

    Our client, a dynamic and rapidly expanding crop protection R&D company, is seeking an experienced Regulatory Affairs Specialist to play a pivotal role in their continued success. The ideal candidate will have a strong background in regulatory affairs within the agrochemical industry and excellent knowledge of US regulatory requirements for agricultural...

  • Regulatory Affairs Specialist

    3 weeks ago

    Montréal, Canada vitaltracer Full time

    Work Term: Permanent - Work Language: English - Hours: 42 to 44 hours per week - Education: Master's degree - Experience: 5 years or more **Tasks**: - Analyze and provide advice on the managerial methods and organization of an establishment - Conduct quality audits - Develop quality management and quality assurance standards - Conduct research to determine...

  • Regulatory Affairs Assistant

    19 hours ago

    Montréal, Canada Innovaderm Research Full time

    The Regulatory Affairs Assistant is responsible for handling regulatory documents and maintaining the Investigator’s Study Files (ISFs) for all studies at the clinical research unit. **RESPONSABILITIES** More specifically, the Regulatory Affairs Assistant must: - Track the signatures of regulatory forms (i.e., QIU, FDA1572, financial disclosure forms)...

  • Senior Medical Writer

    3 weeks ago

    Montréal, QC, Canada Syneos Health Full time

    Senior Medical Writer Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of...

  • Technical Regulatory Affairs Manager, Cmc contract

    4 days ago

    Montréal, Canada Groom & Associes Full time

    **LOCATION**: Montreal, QC **INDUSTRY**: Pharmaceutical **JOB TYPE**: Contract **ESTIMATED DURATION**: Six (6) months from start date **START DATE**: Immediate **VERY IMPORTANT** **HYBRID WORK MODEL**: Ideally 1-2 days a week on site at the Montreal office located in Old Montreal & at the Quebec City production site, but can be fully remote if...

  • Regulatory Affairs Associate and Compliance

    3 weeks ago

    Montréal, Canada Viscofan Canada Full time

    Contribute to establishing and maintaining high quality compliance status of all products handled by Viscofan Canada Inc in accordance with Canadian GMP and Health Canada regulations for the distribution and use of Direct Food Contact packaging. Manage all request from business partners including compliance documents and questionnaires, supplier...

  • Senior Regulatory Affairs Specialist, Operations

    12 hours ago

    Rivière-du-Loup, QC, Canada Amicus Search & Recruitment Full time

    Our client, a dynamic and rapidly expanding crop protection R&D company, is seeking a highly motivated, and experienced Senior Regulatory Professional to play a pivotal role in their continued success. Initially, the role will focus on implementing established regulatory strategies and ensuring compliance. However, as our client's market share expands, this...

  • Spécialiste, Affaires Réglementaires

    3 weeks ago

    Montréal, Canada Jubilant DraxImage Inc. Full time

    ENGLISH version below_ **Spécialiste, Affaires Réglementaires**(Temporaire - 12 mois)** Rejoignez notre équipe dynamique chez Jubilant Radiopharma en tant que Spécialiste, Affaires Réglementaire ! Nous recherchons une personne motivée qui s'épanouit dans un environnement en constante évolution et qui est passionnée par la garantie des normes de...

  • Director Medical Affairs

    3 weeks ago

    Montréal, QC, Canada MedAccess Recruiters Full time

    Role: Director Medical Affairs Oncology This role offers an exciting opportunity to lead the Medical Affairs team in oncology. The successful candidate will provide strategic and operational direction while ensuring alignment with global medical plans. This position is national in scope and preferably based in Montreal. Role Responsibilities: Define the...

  • Analyste, Affaires Réglementaires regulatory

    2 weeks ago

    Montréal, QC, Canada Keurig Dr Pepper Full time

    Job Overview: **Analyste, Affaires réglementaires** permenant, temps plein Montreal, hybride, 3 jours/semaine Lorsque vous travaillez chez KDP Canada, vous plongez au cœur des opérations internes de la troisième plus grande entreprise de boissons au Canada et vous visez un impact positif avec chaque boisson. Vous apprenez comment l'un des 100...

  • Legal Affairs Assistant

    2 weeks ago

    Montréal, Canada Portage Full time

    **At Head Office** Under the supervision of the Director of Legal Affairs and Corporate Secretary, the Legal Affairs Assistant’s main responsibilities to contribute to the efficiency, smooth operation and achievement of the department's objectives. **RESPONSIBILITIES** - Ensures that all of the organization’s policies and procedures are followed and...