Regulatory Affairs Director

6 days ago

Washington, United States Blackrock Neurotech LLC Full time
Job Title: Head of Regulatory Affairs

Company: Blackrock Neurotech LLC

Reports To: CEO

Location: Remote

Job Overview:

Blackrock Neurotech LLC, a pioneering neurotechnology company, is seeking an experienced and visionary Head of Regulatory Affairs to design and execute global regulatory strategies for our Brain-Computer Interface (BCI) platform technology and its applications.

Key Responsibilities:
  • Regulatory Strategy:
    • Develop and implement comprehensive global regulatory strategies for Blackrock Neurotech's BCI platform technology.
    • Design regulatory strategies for BCI applications, ensuring smooth transitions and compliance.
    • Manage regulatory strategies specifically for active implantable Class 2a and 2b medical systems, ensuring compliance with relevant standards and regulations.
    • Oversee the transition and regulatory submission of BCI System through early feasibility studies, first-in-human, investigational use, and clinical trials in the US and parallel systems globally.
    • Develop strategies for interactions with regulatory bodies through breakthrough and similar designations globally.
    • Oversee regulatory approval processes, including FDA pre-market approval (PMA) and 510(k) submissions. Manage relationships with national regulators and policy-makers in the US and abroad.
    • Drive innovation in regulatory approaches, addressing novel regulatory challenges with a strategic and proactive mindset.
  • Clinical Trials:
    • Lead the design and execution of clinical trials to support regulatory submissions for Class 2a and 2b systems. Ensure trials meet regulatory standards and requirements.
    • Oversee international clinical trials, ensuring compliance with diverse regulatory requirements and standards.
  • Interaction with Regulators:
    • Establish and maintain strong relationships with regulatory bodies such as the FDA, Notified Bodies, Authorized Representatives, and other international regulators. Advocate for regulatory pathways that support innovation and patient safety.
    • Serve as a thought leader in the regulatory space, influencing public and regulatory discussions on how BCI technologies should be regulated.
    • Serve as Blackrock Representative for iBCI collaborative community to address BCI ethics, neural data privacy, and data security.
    • Act as Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulations.
  • Leadership:
    • Build and lead a high-performing regulatory affairs team, upleveling the team's capabilities and ensuring alignment with company goals.
    • Collaborate with R&D, clinical, legal, and marketing teams to ensure cohesive regulatory strategies and compliance across the organization.
  • Risk Management and Compliance:
    • Lead preparation and execution of regulatory audits, ensuring compliance with all regulatory requirements.
    • Oversee quality assurance processes, integrating QA with regulatory affairs to ensure product safety and efficacy.

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