Regulatory & Quality Lead for SaMD Wearable Health Tech

Alva Health, Inc.; Dallas (TX); On-site; 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, 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.