Director of Quality and Regulatory

Director of Quality and RegulatoryAvail Medystems is a medical technology company founded in Palo Alto, CA in 2017 to power clinical connectivity and accelerate the advancement of healthcare. Through technology, Avail removes the barriers and inefficiencies of in-person medical collaboration such as travel and costs. Avail is considered the pioneer of "Procedural Telemedicine" with an advanced self-contained hardware/software technology platform that enables remote physicians and medical device industry representatives to instantly join a procedure from an easy-to-use app on their iPad or laptop and communicate two-way with operating physicians. The need for remote clinical connectivity has grown significantly with COVID-19, accentuating the need for more efficient healthcare interactions in the long-term. As a result, Avail is a fast-paced and groundbreaking technology company experiencing rapid growth.Position OverviewThe Director of Quality and Regulatory will lead and oversee the direction, planning and execution of Avail Medsystems'' Quality and Regulatory Affairs in alignment with the Company''s overall direction, meeting key objectives.This position reports to the Vice President of Operations and is located at our headquarters in Santa Clara. Remote employment is an option at the discretion of the Vice President of Operations in accordance with company policies. Responsibilities:Provide Quality and Regulatory leadership and direction to Avail Medysystems. Ensure quality standards and regulatory submissions are met within designated timelines.Act as Management Representative for the company with dotted line reporting to the CEO.Provide strategic direction and guidance to Executive Management regarding quality timelines for new and revised products and/or processes, and/or regulations & guidances.Lead Quality Design Assurance activities for new and existing products including enterprise and applications Cloud-based software.Provide executive responsibility, leadership and expertise in maintenance of Quality Management System (ISO 13485 Certification including CMDCAS, MDR compliance; 21 CFR 820 compliance; and other regulations that may become applicable).Foster a culture of excellence, professional integrity and respect for patient safety, ensuring that all necessary management systems are in place to make these high principles actionable and assure compliant practices that will result in the Company''s ultimate medical and commercial success. Provide Quality and Regulatory oversight of any contract manufacturing organizations supporting Avail MedsystemsDevelop and update QMS processes to support Medical Device Data Systems (MDDS), SaaS, and Software as a Medical Device (SaMD) applications in alignment with the advancing initiatives of the FDA''s Digital Health Center for Excellence.Play an active role in design reviews to assess quality, compliance and business risk.Host and lead all external audits with Notified Bodies, FDA, FDB, etc. Respond to all corrective actions in a timely manner and drive all issues to closure. Interact with FDA/Notified Bodies/ Foreign Regulatory agencies to address and resolve issues. Work with cross-functional teams in preparation of regulatory filings, including 510(k) notifications, IDE correspondence, Technical Dossiers, etc. Internally, partner with Operations group, providing quality oversight of manufacturing line, tooling and calibration programs, material review board management and release of clinical and commercial product. Trend and report quality metrics.Responsible for measuring and reporting on Product Reliability Programs and impact on customer satisfaction and adoption. Compile data, tracking and trending corrective actions, and partner with Field Service, Manufacturing and/or R&D to recommend and drive product improvement projects to resolution consistent with company objectives.Work with R&D/Product teams on new product development through project phases, providing input on process quality requirements.Gather information, provide detailed reporting and provide management with key updates, including Management Review.Conduct internal and external audits to ensure compliance with all quality standards. Responsible for initiating corrective actions and driving root cause analysis and resolution of issues through team members and suppliers as necessary. Lead OUS product registrations and Regulatory strategyResponsible for CAPA program (including customer complaints), Audit program, Document Control and Training compliance throughout the organization. Review and approve Marketing literature in accordance with applicable regulatory requirementsDevelop and drive team and company quality goals and objectives.Budgetary responsibility for all Quality and Regulatory related expenses Requirements/Qualifications:BS Degree or higher in life sciences or engineering and a minimum 10 years'' experience in medical device design and manufacturing environment A practical and working knowledge of ISO 13485:2016, FDA 21 CFR 820, MDRA practical and working knowledge of MDDS and SaMDA proven track record with regulatory filings and understanding market requirementsQA/RA leadership, planning, and project managementMust be able to write clear technical descriptions of rationales, designs, observations, conclusions, and implementation instructions.Desired Skills, Not required:Ablility to manage internal QA/RA team and work well cross-functionallly within all levels of the organizationDetail oriented and well organized with excellent written and verbal communication skillsAbility to accomplish objectives and manage multiple tasks and projects with minimal supervisionFamiliarity with software quality processes and tools required for high-quality software and systems release.Performs well in highly dynamic development teams.Work Location: Santa Clara, CA - provided by Dice

Created: 2025-09-06