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WizeHire, Inc
San Francisco, CA, United States
We are seeking a dynamic and visionary Chief Technology Officer (CTO) to lead the technical development of our groundbreaking AI hardware device and software platform. Someone who can push the limits of innovation around running LLMs, machine learning algorithms, computer vision, and voice AI, on devices using a proprietary chipset. As a key member
Job Source: WizeHire, IncKid Company
Palo Alto, CA, United States
Job Posting: Chief Technology Officer (CTO) Company: KID Company Location: San Francisco, Bay Area About Us: KID Company is an AI startup, founded by Robert LoCascio, who was the Founder and former CEO of LivePerson for twenty-eight years. The mission of KID is to create the world’s best “Responsive” AI device that taps into the imaginations of
Job Source: Kid CompanyBybit
San Francisco, CA, United States
We are seeking a visionary and dynamic Chief Technology Officer (CTO) with a strong software background and extensive experience in top Internet companies. The ideal candidate will possess strong leadership qualities and a proven track record of guiding teams through challenging situations to achieve success. This role demands a tough yet inspiring
Job Source: BybitinBuild
San Francisco, CA, United States
[Full Time] Chief Technology Officer at inBuild (United States) | BEAMSTART Jobs Chief Technology Officer inBuild United States Date Posted 07 Jun, 2023 Work Location San Francisco, United States Salary Offered $85000 — $170000 yearly Job Type Full Time Experience Required 3+ years Remote Work Yes Stock Options Yes Vacancies 1 available Posit
Job Source: inBuildKidCo.AI
San Francisco, CA, United States
We are seeking a dynamic and visionary Chief Technology Officer (CTO) to lead the technical development of our groundbreaking AI hardware device and software platform. Someone who can push the limits of innovation around running LLMs, machine learning algorithms, computer vision, and voice AI, on devices using a proprietary chipset. As a key member
Job Source: KidCo.AICommunity Health Center Network Inc
San Leandro, CA, United States
Salary Range: $166,200.00 To 204,000.00 Annually Organizational Description The Community Health Center Network (CHCN), sister organization to the Alameda Health Consortium, is made up of the eight federally qualified community health centers in Alameda County. CHCN functions as the managed care MSO for our health centers, contracting with the Al
Job Source: Community Health Center Network IncConfidential
San Francisco, CA, United States
Chief Product and Technology Officer About the Company Prominent insurance holding company Industry Insurance Type Public Company Founded 2004 Employees 5001-10,000 Categories Financial Services Consulting & Professional Services Insurance About the Role The Company is seeking a Chief Product & Technology Officer to lead and develop the product,
Job Source: ConfidentialMoonshot Brands
Oakland, CA, United States
[Full Time] Chief Technology Officer (CTO) at Moonshot Brands (United States) | BEAMSTART Jobs Chief Technology Officer (CTO) Moonshot Brands United States Date Posted 25 Jun, 2022 Work Location Oakland, CA, United States Salary Offered Not Specified Job Type Full Time Experience Required 3+ years Remote Work Yes Stock Options No Vacancies 1
Job Source: Moonshot BrandsSan Mateo, CA, United States
Job Summary:
The Principal Regulatory Affairs (RA) Specialist will work with the team to support the Regulatory Affairs department to ensure the overall regulatory compliance with the applicable regulatory bodies and ensure compliance with the Presidio Quality Management System (QMS). The Principal Regulatory Affairs Specialist is responsible for participating on design control projects, evaluating document change orders for RA assessment, evaluating design change forms for RA assessment, drafting regulatory submissions, review and sign off on Regulatory/Quality documents, i.e., NCRs, CAPAs, PRAs, etc. Assist in planning of regulatory related projects in alignment with company goals.
Essential Duties and Responsibilities:
Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.
Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and reports.
Work with R&D on Risk Management and review and approve Risk Management File(s).
Responsible for compilation of Class III medical device Regulatory submissions (IDE/supplements, PMA/supplements, Design Dossier, and any required international submissions.
Responsible for review/approval of Document Change Orders (DCOs), Design Change requests and labeling; including assessments of regulatory impact.
Responsible for Change notifications to notified body and any additional regulatory notifications.
Reviews Clinical reported events during the clinical study are documented, logged, and tracked accordingly and evaluated for regulatory reporting requirements.
Responsible for Regulatory sign-off of Product Release approvals for shipment of Presidio materials.
Responsible for review and sign off on NCRs, CAPAs, etc. for regulatory signature.
Assists with internal audits and external audits, driving issues to closure as required.
Responsible for product packaging/labeling requirements and ensuring all materials are conforming with applicable regulatory requirements.
Maintain regulatory documentation, registrations and device listings both domestic and international markets.
Review and interpret regulatory rules and ensure that they are communicated through company policies and procedures.
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
Write/revise departmental SOPs as required.
Provide guidance and direction to subordinate regulatory personnel to assist in personal and professional development.
Comply with Presidio Medical's quality system requirements as well as any applicable regulatory requirements.
Comply with all health and safety regulations, policies, and work practices.
Other duties as assigned.
Qualification Requirements:
Experience:
A minimum of 10+ years of experience in Regulatory Affairs, 8+ with Masters degree
5+ years' experience in the Medical Device industry, preferably Class III active medical devices.
Regulatory Affairs Certification expected (US)
Experience with design controls, including mechanical, software/firmware and risk management review.
Experience with FDA IDE, PMA and Australia submissions.
Knowledge/skills/Abilities:
Knowledgeable of FDA (21CFR 812, 820), ISO 13485, and ISO14971
Thorough understanding of FDA and applicable international regulations.
Excellent written and oral communication, and technical writing and editing skills.
Ability to write clear and understandable technical documentation.
Skilled at analyzing and summarizing data.
Ability to manage and prioritize multiple projects.
Ability to follow written and verbal directions with a high level of accuracy.
Understanding of design verification and validation methods
The ability to work independently with minimal supervision.
Extreme attention to detail.
Excellent problem-solving skills
Excellent interpersonal skills and a spirit of teamwork.
Education:
Bachelor of Science in an Engineering or Scientific similar field.
Physical Demands:
Varied sitting, standing, and walking.
Ability to lift and carry 50lbs. or less.
*This role is not eligible for sponsorship.
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Email Alert for Chief Technology Officer jobs in San Mateo, CA, United States
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