Current jobs related to Regulatory Affairs Director - Australia - Blackrock Neurotech LLC

  • Senior Director, Blockchain and Digital Assets Leader

    2 weeks ago

    Australia Fti Consulting, Inc Full time

    About the RoleFTI Consulting's Blockchain and Digital Assets practice is experiencing rapid growth, driven by innovation in blockchain and digital asset technology. We are seeking a dynamic and experienced Senior Director to join our team as we continue to build and expand our services. The successful candidate will have a deep understanding of delivering...

  • Responsible Dam Engineer/Geotechnical Engineer

    2 months ago

    Australia NES Fircroft Full time

    About the RoleNES Fircroft is partnering with a global resources client to fill a critical position for a Responsible Dam Engineer/Geotechnical Engineer (Principal) to join their site-based team on a 12-month contract.The JobThis role is offered on a 2/1 roster - 1 day travel in, 12 days on site, 1 day travel back. Regular exposure to outdoor conditions and...

  • Client Program Manager, Gas

    2 months ago

    Australia Plains Picarro, Inc Full time

    **Client Program Manager, Gas** **Location: Australia** **Job Term: Full-Time** **The Opportunity**:Picarro is seeking a Client Program Manager to support our Gas APAC team (remote with expected travel 30-50% of the time. **Responsibilities**: - Work directly with regional sales account managers - Support Sales Directors with expertise and field...

Regulatory Affairs Director

2 months ago

Australia Blackrock Neurotech LLC Full time
Job Title: Regulatory Affairs Director

Blackrock Neurotech LLC, a pioneering neurotechnology company, is seeking an experienced and visionary Regulatory Affairs Director 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, ensuring compliance with relevant standards and regulations.
  • Spin-Off Applications: Design regulatory strategies for BCI applications pre and post spin-off, ensuring smooth transitions and compliance.
  • Implantable Tech (Class 2a/2b): Manage regulatory strategies specifically for active implantable Class 2a and 2b medical systems, ensuring compliance with relevant standards and regulations.
  • Product Development: 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.
  • Breakthrough: Develop strategies for interactions with regulatory bodies through breakthrough and similar designations globally.
  • Regulatory Approval: 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.
  • Innovation: Drive innovation in regulatory approaches, addressing novel regulatory challenges with a strategic and proactive mindset.
Clinical Trials:
  • Design and Oversight: 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.
  • International Trials: Oversee international clinical trials, ensuring compliance with diverse regulatory requirements and standards.
Interaction with Regulators:
  • US and International: 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.
  • Thought Leadership: Serve as a thought leader in the regulatory space, influencing public and regulatory discussions on how BCI technologies should be regulated.
  • Collaboration: Serve as Blackrock Representative for iBCI collaborative community to address BCI ethics, neural data privacy, and data security.
  • Representative: Act as Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulations.
Leadership:
  • Team Management: Build and lead a high-performing regulatory affairs team, upleveling the team's capabilities and ensuring alignment with company goals.
  • Cross-Functional Collaboration: Collaborate with R&D, clinical, legal, and marketing teams to ensure cohesive regulatory strategies and compliance across the organization.
Risk Management and Compliance:
  • Audit Preparation: Lead preparation and execution of regulatory audits, ensuring compliance with all regulatory requirements.
  • Quality Assurance: Oversee quality assurance processes, integrating QA with regulatory affairs to ensure product safety and efficacy.