Chief Scientific Officer

hace 3 semanas

Lima Metropolitana, Perú CARI Health A tiempo completo

Overview The CTO/CSO will lead the development and commercialization of innovative point-of-care and continuous in vivo medication monitoring solutions. This role requires a visionary leader with a proven track record in bringing medical devices from R&D to market, particularly in biosensing, diagnostics, and wearable health technologies. The ideal candidate will bridge technical innovation with clinical and commercial strategy, ensuring alignment with regulatory and industry standards. About the Role This role combines strategic leadership with hands-on technical execution, ideal for a candidate passionate about transforming medication monitoring through cutting-edge technology. Responsibilities Define and execute the technical roadmap for point-of-care applications and future continuous monitoring systems, integrating biosensor technology, and data analytics. Oversee R&D efforts to advance in vivo measurement technologies, ensuring scalability and clinical relevance. Lead the end-to-end development of FDA compliant devices, including prototyping, validation, and regulatory submissions. Collaborate with cross-functional teams (engineering, clinical, regulatory) to accelerate time-to-market for point-of-care solutions. Spearhead the adoption of advanced technologies (e.g., AI/ML, microfluidics, wireless telemetry) to enhance device accuracy, usability, and patient outcomes. Design architectures for real-time data processing and secure cloud integration. Regulatory & Compliance Oversight Ensure adherence to ISO 13485, FDA 21 CFR Part 820, and GDPR/HIPAA standards for data security and device safety. Manage relationships with regulatory bodies and external partners for certifications and clinical trials. Team Building & Stakeholder Collaboration Recruit and mentor technical teams in biosensor development, software engineering, and clinical research. Partner with clinicians, clinic operators and payers to validate use cases and drive adoption. Qualifications Advanced degree (PhD preferred) in Chemistry, or related field. 10+ years of experience in MedTech, with a focus on point-of-care diagnostics and/or continuous monitoring devices (e.g., glucose monitors, biosensors). Proven success in commercializing FDA Class II/III medical devices, including De Novo, PMA or 510(k) submissions. Deep expertise in biosensor technology, electrochemical sensing, or optical measurement systems. Strong understanding of clinical workflows and reimbursement landscapes for in vivo and in vitro diagnostics. Preferred Skills Familiarity with Agile product development and ISO 13485 QMS. Expertise in pharmacokinetics, drug monitoring, or biosensing technologies. Pay range and compensation package Includes base salary, health insurance, vacation, and participation in the company's stock option plan. Equal Opportunity Statement We are an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or veteran status. Seniority level Executive Employment type Full-time Job function Strategy/Planning, Management, and Manufacturing Industries Medical Equipment Manufacturing Biotechnology Research Hospitals and Health Care #J-18808-Ljbffr

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