Medical Quality & Regulatory Specialist

Alva Health is an early-stage digital health company developing an AI/ML-enabled wearable neuromonitoring platform, with the first indication in real-time stroke detection. A Yale University spinout backed by Techstars, the National Science Foundation, and the National Institutes of Health, our mission is to transform stroke monitoring and response by enabling timely intervention through continuous, at-home detection of neurological events. Our patented technology uses wearable sensors to identify hemiparesis, one of the earliest signs of stroke onset in real time, with the goal of dramatically improving emergency response and increasing the number of patients receiving life-saving reperfusion therapies.

Alva Health was named the Grand Prize winner out of 1,100 applicants at the 2021 Med Tech Innovator competition and has raised $2M in non-dilutive grant funding to date. As we move toward FDA 510(k) submission and prepare for our next stage of growth, we are seeking a Medical Quality & Regulatory Specialist to establish and manage our Quality Management System (QMS), support regulatory submissions, and ensure compliance with FDA, ISO, and SaMD standards.

This is an opportunity to shape the regulatory and quality foundation of a mission-driven healthtech company advancing breakthrough stroke care.

Set up and maintain the company’s QMS in accordance with FDA 21 CFR Part 820 and ISO 13485

Draft, revise, and manage controlled documentation, including SOPs, work instructions, templates, and design history files

Support internal audits, CAPA processes, and continuous improvement initiatives

Assist in preparing and organizing documentation for FDA 510(k) pre-submission and final submission package

Oversee software-related quality documentation (SRS, V&V plans, traceability matrices, risk analysis per IEC 62304 and ISO 14971)

Collaborate with engineering teams to ensure appropriate controls for software lifecycle management, SaMD documentation, and cybersecurity considerations

Maintain training records and ensure company-wide QMS compliance, with a focus on software development and documentation processes

Ensure traceability across design control elements, verification/validation activities, and clinical documentation

Support grant submissions, grants management, technical reports, and publications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in quality and/or regulatory roles within a medical device company
• Experience with QMS setup and maintenance, ideally for a Class II medical device
• Familiarity with FDA 510(k) submissions, regulatory pathways, and design control requirements
• Knowledge of ISO 13485, ISO 14971, FDA QSR (21 CFR Part 820), and software standards such as IEC 62304
• Strong organizational and documentation skills, with hands‑on experience in technical files and software records
• Ability to work in a startup environment with cross‑functional collaboration and limited oversight

• Experience with digital health, wearable medical devices, or software‑enabled medical products
• Familiarity with SaMD regulatory frameworks and applicable guidance (FDA SaMD, IMDRF)
• Experience with eQMS platforms or document control systems
• RAC (Regulatory Affairs Certification) or similar credentials
• Understanding of data privacy, security, and cybersecurity considerations in regulated software

• Mission‑driven company building a transformational solution to improve outcomes for patients at high risk of stroke
• Opportunity to establish the quality and regulatory foundation of a growing health tech startup
• Work closely with senior regulatory leadership with prior FDA and market‑leading product…