Medical Quality & Regulatory Specialist

Alva Health, Inc.; Dallas, Northern (TX, KY); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Alva Health, Inc. is seeking a Medical Quality & Regulatory Specialist to establish and manage the QMS, support regulatory submissions, and ensure compliance with FDA, ISO, and SaMD standards. You will collaborate with engineering on software lifecycle controls and cybersecurity considerations.

The role focuses on building a robust quality and regulatory foundation for a startup advancing real-time stroke detection technology within a fast-paced environment.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of quality and/or regulatory experience in medical devices.
• Experience with QMS setup and maintenance for Class II devices.
• Familiarity with FDA 510(k) submissions and design control.
• Knowledge of ISO 13485, ISO 14971, FDA QSR (21 CFR Part 820).
• Strong documentation and cross-functional collaboration in a startup environment.

Responsibilities

• Set up and maintain the company’s QMS per FDA 21 CFR Part 820 and ISO 13485
• Draft, revise, and manage controlled documentation and design history files
• Support internal audits and CAPA processes
• Prepare FDA 510(k) pre-submission and final submission documentation
• Oversee software-related quality documentation (SRS, V&V, traceability)
• Collaborate with engineering on software lifecycle controls and cybersecurity
• Maintain training records and ensure company-wide QMS compliance
• Ensure traceability across design controls and verification/validation

Skills

Regulatory affairs

Quality management

Documentation

Audits

Software lifecycle

Education

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

Tools

eQMS platforms

Job description

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 MedTech 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.

Your Role at Alva Health:

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

REquired Qualifications:

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

Preferred Qualifications:

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

Our Commitment to You:

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 approval experience

Collaborative and flexible team culture with long‑term growth opportunities

Exposure to both hardware and software development in a fast‑paced environment

Equal Opportunity Employer:

Alva Health is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, or disability status

We view our team’s diversity as a competitive advantage, and we are committed to building a diverse and inclusive environment for people of all backgrounds. We highly encourage applications from members of socio‑economically disadvantaged groups, underrepresented groups in science and engineering, persons with disabilities, veterans of the U.S. Armed Forces, and first‑generation college graduates.

Eligibility Requirements:

United States Citizen, National, or Permanent Resident of the United States

Competitive compensation and equity commensurate with experience

Premium medical, dental and vision insurance, life insurance, holidays and three weeks PTO