AI-Powered QA/RA Consultant for MedTech

Ketryx Corporation; Boston (MA); Hybrid; USD 130,000 - 150,000; Full time

Benefits offered by this job

Equity options

Hybrid schedule

Job summary

Ketryx is seeking a QA/RA Consultant in Boston, MA to lead QMS implementations and regulatory strategies for medical device clients using our AI-powered compliance platform. This hybrid, full-time role places you at the forefront of regulatory excellence and quality systems deployment.

You will help shape the future of regulatory affairs, driving repeatable QMS deployment processes and ensuring high-quality, life‑saving devices.

Qualifications

• 5–8 years of quality systems management experience in medical devices.
• Experience with ISO 13485, MDSAP, and GxP.
• Strong ability to lead QMS deployments and regulatory strategies.
• Experience with AI-powered regulatory tools is a plus.

Responsibilities

• Lead QMS setup and deployment for medical device clients.
• Own QMS templates and regulatory frameworks.
• Provide expert consulting on ISO 13485, MDSAP, and other standards.
• Scale operations for high-growth clients.
• Develop repeatable QMS deployment processes leveraging AI.
• Shape the future of regulatory affairs through product development.
• Work independently on complex regulatory projects.
• Ensure customer success across the engagement lifecycle.

Skills

Quality management

ISO 13485 knowledge

GxP compliance

AI/regulatory tech

Cybersecurity for medical devices

Regulatory consulting

Independent work

Client-facing communication

Notified Body submissions

Regulated environments

Tools

eQMS implementation

Regulatory submission software

Job description

Ketryx is seeking a QA/RA Consultant in Boston, MA to lead QMS implementations and regulatory strategies for medical device clients using our AI-powered compliance platform. This hybrid, full-time role places you at the forefront of regulatory excellence and quality systems deployment.

You will help shape the future of regulatory affairs, driving repeatable QMS deployment processes and ensuring high-quality, life‑saving devices.