Medical Quality & Regulatory Specialist

MedTech Innovator; Dallas, Northern (TX, KY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Premium medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Job summary

Alva Health in Dallas, TX is seeking a Medical Quality & Regulatory Specialist to build and maintain a robust QMS compliant with FDA 21 CFR Part 820 and ISO 13485, focusing on SaMD and software lifecycle documentation.

You will lead regulatory submissions (FDA 510(k) pre/submission), manage design history files and risk analyses per ISO 14971, and collaborate with engineering to embed quality across hardware and software development.

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 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.

Responsibilities

• 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 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.

Skills

Quality management

Regulatory affairs

Documentation

Education

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

Job description

Quality Assurance, Compliance / Regulatory

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