QA & Regulatory Affairs Lead - Wearable Ultrasound Tech

Bcicglobal; Boston (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Sonologi Inc. is seeking a hands-on Quality Assurance and Regulatory Affairs Specialist to support wearable ultrasound program through design verification, regulatory submissions, and cross-functional collaboration.

The ideal candidate has 3–5 years of medical-device QA/RA experience, with strong documentation, scheduling, and project-management skills to align with project timelines and regulatory expectations.

Qualifications

• Bachelor's degree in engineering, life sciences, regulatory affairs, quality assurance, or related field.
• 3–5 years of combined QA and regulatory affairs in medical-device industry.
• Experience supporting FDA submissions (510(k)) and FDA guidance; familiarity with standards.

Responsibilities

• Support ISO 13485 QMS implementation and maintenance; manage document control and CAPA.
• Assist FDA 510(k) submissions, including plans, questions, and eSTAR responses.
• Coordinate usability/human factors activities per IEC 62366-1 and FDA guidance.
• Plan and coordinate clinical feasibility and performance studies with sites and IRBs.
• Manage external laboratories; track test plans, reports, and submission readiness.

Skills

QA/RA experience

FDA submissions

Design controls

ISO 13485

Risk management ISO14971

Regulatory strategy

Documentation

Clinical study coordination

External labs management

Project management

Technical writing

Education

Bachelor's degree (engineering/life sciences/regulatory/QA)

Tools

Smartsheet

Jira

eQMS

Job description

Sonologi Inc. is seeking a hands-on Quality Assurance and Regulatory Affairs Specialist to support wearable ultrasound program through design verification, regulatory submissions, and cross-functional collaboration.

The ideal candidate has 3–5 years of medical-device QA/RA experience, with strong documentation, scheduling, and project-management skills to align with project timelines and regulatory expectations.