Chief Regulatory Compliance Officer for Medical Technology

hace 6 días

remoto, Perú Tether Operations Limited A tiempo completo
Company Overview
Tether Operations Limited is a pioneering company in the development and implementation of innovative financial solutions. Our mission is to drive technological advancements and democratize access to finance, education, data, and technology worldwide.

Job Description
We are seeking an experienced Chief Regulatory Compliance Officer to lead our medical technology regulation efforts. This key role will be responsible for designing and executing global regulatory strategies for our Tether Evo business vertical. The ideal candidate will have expertise in medical technology regulation, including pre-market approval processes, clinical trial oversight, and interaction with regulatory bodies in the US and internationally.

Key Responsibilities
- Develop and execute regulatory strategies to ensure compliance with relevant national and international regulations
- Identify preferable markets for operation and ensure the company's readiness for compliance
- Lead or participate in regulatory agency interactions, engaging with authorities, industry bodies, and policymakers to shape the regulatory landscape for biotech
- Provide analysis on global regulatory policies and advise executive leadership on potential regulatory risks and opportunities
- Drive initiatives to influence regulatory frameworks and monitor for change across regulations to ensure proactive compliance

Requirements
- Minimum 10 years of 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
- Ability to apply knowledge of key regulatory frameworks strategically and operationally

What We Offer
- Estimated annual salary: $140,000-$180,000 depending on qualifications and experience
- Opportunity to work with a pioneering company in the field of medical technology regulation
- Collaborative and dynamic work environment

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