Regulatory Affairs Strategist

hace 2 semanas


Buenos Aires, Buenos Aires C.F., Argentina Aeros A tiempo completo

Aeros is seeking an experienced Regulatory Affairs Strategist to join our team. In this role, you will lead the development and execution of regulatory strategies to enable market access for our company in the Brain-Computer Interface (BCI) space.

About the Role:
  • Develop and execute global regulatory strategies to ensure compliance with relevant national and international regulations.
  • Lead interactions with regulatory authorities, industry bodies, collaborative communities, and policymakers to shape the regulatory landscape for biotech.
  • Analyze global regulatory policies and advise executive leadership on potential regulatory risks and opportunities.
About You:
  • Minimum of 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.


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