Head of Regulatory Affairs

Blackrock Neurotech is 100% focused on improving human lives through neuroscience research and technology. The passion and dedication behind this mission has nurtured a dynamic, enjoyable and fulfilling corporate environment in which learning and growth are commonplace. We operate in an innovative field that requires our staff to meet the highest standards. Every step of the way, we encourage one another by providing continuous motivation and promoting a healthy work environment.Job Title:

Head of Regulatory Affairs

Job Reports To:

CEOLocation:

Salt Lake City or RemotePosition Overview:Blackrock Neurotech, a leader in neurotechnology, 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. This role requires deep expertise in medical technology regulation, including pre-market approval processes, clinical trial oversight, and interaction with regulatory bodies both in the US and internationally.Qualifications:Experience: 10+ years of experience in medical technology regulation, with a strong background in neurotechnology and implantable devices (Class 2a and 2b).Regulatory Expertise: Proven ability to interact effectively with US and international regulators, including the FDA. Experience with PMA processes, 510(k) submissions, and clinical trials.Communication: Exceptional communication skills, both written and verbal, with experience in public speaking and representing the company in regulatory discussions.Leadership: Strong leadership skills with experience managing teams with diverse regulatory goals. Visionary approach to regulatory strategy and innovation.International Experience: Extensive experience with international regulatory environments, including Europe (Notified Bodies, Authorized Representatives, etc.), Australia, the Gulf region, and China.Additional Skills: A second language is a plus. Experience in smaller companies, understanding their limitations and restrictions, is highly desirable.Key Responsibilities:Regulatory Strategy:Global Regulatory Strategy: Design and implement comprehensive global regulatory strategies for Blackrock Neurotech’s BCI platform technology.Spin-Off Applications: Develop 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.

#J-18808-Ljbffr