MedTech Quality & Regulatory Lead — QMS & 510(k)

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

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.