Leader: Indication Prioritization and Clinical & Regulatory Strategy (Nano-Electronic Neural Implants)
BOSTON, MAPosted 30+ days ago
Job summary
Job overview
The Leader of Indication Prioritization and Clinical & Regulatory Strategy at Cahira Technologies drives the human-translation roadmap and indication prioritization for their nano-electronic neural implant platform, impacting clinical success and market launch.
Responsibilities and impact
The role involves selecting the beach-head disease indication, building and executing regulatory and clinical strategies across global jurisdictions, and defining milestone plans from technology advancement through market approval.
Experience and skills
Requires 10+ years in Class III active implantable devices with 5+ years in neural implants, experience in FDA approval and commercial launch of neural devices, deep regulatory knowledge, advanced degree in relevant fields, and strong communication skills; preferred qualifications include experience with nano-scale implants, Breakthrough Device Designation, regulatory certifications, and familiarity with AI/ML-enabled implant algorithms.
Work environment and culture
The candidate should thrive in a fast-paced, resource-constrained startup environment and be capable of scaling teams rapidly, indicating a dynamic and growth-oriented culture.
Company information
Cahira Technologies develops the world's first non-surgical, wireless nano-electronic implants crossing the intact blood-brain barrier for precise neuromodulation, preparing for first-in-human studies and commercialization.
Unique job features
The role uniquely involves leading indication prioritization and regulatory strategy for an innovative nano-electronic neural implant platform integrating AI/ML-enabled digital companions.
Company overview
Cahira Technologies is an MIT spinoff company based in Boston, focused on developing novel sub-cellular sized wireless electronic devices. The company leverages advanced research in neuroscience, nanoelectronics, and bioengineering to create innovative neural interfaces and related technologies. Their business model centers on commercializing these cutting-edge devices, likely targeting applications in neuroscience research, medical devices, and neural engineering. Founded by Himanshu Ranjan, Cahira Technologies is recognized for building what is described as the world's first devices of their kind, positioning the company at the forefront of wireless neural technology innovation. This unique expertise and MIT heritage make Cahira Technologies a notable player in the intersection of biotechnology and electronics.
How to land this job
Position your resume to highlight your extensive leadership in indication prioritization and clinical-regulatory strategy for neural implants, emphasizing your 10+ years in Class III active implantable devices and direct experience with neural or neuromodulation implants.
Focus on showcasing your end-to-end success in bringing neural implant devices from late pre-clinical stages through FDA approval and commercial launch, including familiarity with FDA IDE, PMA, De Novo, Breakthrough Devices Program, and EU MDR regulatory pathways.
Apply through multiple platforms such as Cahira Technologies' official corporate careers page, LinkedIn job postings, and industry-specific medical device job boards to maximize your application visibility.
Connect on LinkedIn with professionals in Cahira’s regulatory, clinical development, and neuromodulation divisions, using ice breakers like commenting on Cahira’s pioneering wireless nano-electronic implants or asking about their experience navigating FDA approvals for breakthrough neurotechnology.
Optimize your resume for ATS by incorporating key terms from the job description such as 'indication prioritization,' 'clinical regulatory strategy,' 'FDA IDE,' 'Breakthrough Device Designation,' 'neural implants,' and 'AI/ML-enabled algorithms' to ensure your resume passes automated screenings.
Leverage Jennie Johnson's Power Apply feature to automate tailored resume optimization, multi-channel applications, and targeted LinkedIn networking, allowing you to focus on preparing for interviews and strategic follow-ups.
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