About Alva Health:

We are an early-stage digital health startup developing an AI/ML enabled wearable medical device to detect and monitor neurological events. Our mission is to transform how high-risk patients are monitored and cared for, leveraging real-time data to enable timely intervention and improve outcomes. As we move toward FDA 510(k) submission and scale our operations, we are looking for a Medical Quality & Regulatory Specialist to join our team.

Role Overview

As our Medical Quality & Regulatory Specialist, you will play a critical role in establishing and maintaining our Quality Management System (QMS), managing design and development documentation, and assisting with regulatory submissions. You will work closely with cross-functional teams—including software, hardware, operations, and external partners—to ensure compliance with FDA regulations, ISO standards, and SaMD requirements. This role will be particularly focused on supporting the quality and regulatory processes related to software-enabled medical devices

Responsibilities:

• Set up and maintain the company’s Quality Management System (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 the FDA 510(k) pre-submission and final submission package.
• Oversee software-related quality documentation, including software requirements specifications (SRS), software verification and validation (V&V) plans, traceability matrices, and risk analysis (in line with 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 special attention to software development and documentation processes.
• Ensure traceability across design control elements, verification/validation activities, and clinical documentation for both hardware and software components.
• Collaborate with management and engineering teams on technical writing activities such as grants, technical reports and publications.
• Support the grant submissions process, grants management and compliance as needed.

Qualifications:

• Bachelor’s degree in a relevant field (e.g., Engineering, Life Sciences)
• Minimum of 3 years of experience in quality and/or regulatory roles within a medical device company.
• Experience working 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, including hands-on experience with technical files and software development 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 documents (e.g., 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.
• United States Citizen, National, or Permanent Resident of the United States