Regulatory Affairs Strategist

hace 5 días


Madrid, Madrid, España Tether Operations Limited A tiempo completo

Job Summary

We are seeking a highly skilled Regulatory Affairs Strategist to join our team at Tether Operations Limited. This is an exceptional opportunity for an experienced professional to lead the development and execution of global regulatory strategies, ensuring compliance with relevant national and international regulations.

About the Role

The successful candidate will have a minimum of 10 years' experience in medical technology regulation, with a strong background in neurotechnology and implantable devices (Class 2a and 2b or Class 3). They will be responsible for 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.

Key Responsibilities:

  • Develop and execute global regulatory strategies, ensuring compliance with relevant national and international regulations
  • Identify preferable markets from which to operate and ensure the company's readiness for compliance with relevant national and international regulations
  • Lead the development and execution of regulatory submissions, including pre-market approval processes, clinical trial oversight, and interaction with regulatory bodies both in the US and internationally
  • Collaborate with internal teams (e.g., RD, 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

Requirements

To be successful in this role, you will need:

  • A minimum of 10 years' 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

Benefits

This is an exciting opportunity to join a dynamic team and contribute to the growth and success of Tether Operations Limited. The salary for this role is $140,000 - $160,000 per year, depending on experience, with excellent benefits and opportunities for career advancement.



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