Regulatory & Quality Lead, Medical Devices (SaMD)

Alva Health Inc.; Mission (KS); On-site; USD 110,000 - 140,000; Full time

Job summary

Alva Health Inc. seeks a Medical Quality & Regulatory Specialist to establish and manage our QMS, support FDA/ISO submissions, and ensure SaMD compliance.

You will work closely with engineering to implement lifecycle controls, risk management, and documentation processes essential for our stroke-monitoring platform. You will contribute to preparing FDA submissions, maintaining traceability, and advancing the regulatory framework as we move toward FDA clearance and ISO certification in a

Qualifications

• BS degree in engineering, life sciences or related field.
• 3+ years in quality and/or regulatory roles within a medical device company.
• Experience setting up and maintaining a QMS for Class II devices.
• Familiarity with FDA 510(k) submissions and design control requirements.
• Knowledge of ISO 13485, ISO 14971, FDA QSR (21 CFR Part 820).
• Experience with software lifecycle documentation (SRS, V&V, risk analysis).
• Ability to work in a startup with cross-functional teams.

Responsibilities

• Set up and maintain the company’s QMS per FDA 21 CFR Part 820 and ISO 13485.
• Draft, revise, and manage controlled documentation (SOPs, templates, DHF).
• Support internal audits, CAPA, and continuous improvement initiatives.
• Assist in preparing FDA 510(k) pre-submission and final submission packages.
• Oversee software-related quality docs (SRS, V&V plans, traceability).
• Collaborate with engineering to ensure software lifecycle controls and cybersecurity considerations.
• Maintain training records and ensure company-wide QMS compliance.
• Ensure traceability across design controls, verification/validation, and clinical documentation.
• Support grants submissions and technical reports.

Skills

Quality mgmt

Regulatory affairs

Documentation

Cross-functional collab

Startup environment

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

eQMS platforms

Job description

Alva Health Inc. seeks a Medical Quality & Regulatory Specialist to establish and manage our QMS, support FDA/ISO submissions, and ensure SaMD compliance.

You will work closely with engineering to implement lifecycle controls, risk management, and documentation processes essential for our stroke-monitoring platform. You will contribute to preparing FDA submissions, maintaining traceability, and advancing the regulatory framework as we move toward FDA clearance and ISO certification in a