AI Native Qa/Ra Lead (Medtech)

TL;DR

AI Native QA/RA Lead (Medtech): Leading quality management system implementations and regulatory compliance strategies for medical device clients, scaling an AI-powered compliance platform. Focus on driving repeatable QMS deployment processes and ensuring the highest quality standards for life-saving medical devices.

Location: Boston, Massachusetts (hybrid), USA (remote), OR Toronto (remote). Preference for candidates within the Boston area to work a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). Remote and Toronto (remote) candidates may be considered, as well. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.

Salary: $130,000 - $150,000, plus equity options. (Compensation dependent on experience level)

Company

hirify.global is saving and improving lives by making medical software safe and reliable, empowering teams to create safe, secure, and compliant products used by patients and providers worldwide.

What you will do

• Lead Quality Management System (QMS) setup and deployment for medical device clients.
• Own and manage QMS templates and regulatory compliance frameworks.
• Provide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards.
• Scale operations to support high-growth clients.
• Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance.
• Ensure customer success across the entire customer engagement lifecycle.

Requirements

• 4-8 years of experience in quality systems management, management representative or senior specialist role.
• Familiar with eQMS implementation, validation and implementation.
• Deep expertise in Quality Management System setup, sub-systems, and implementation.
• Strong knowledge of ISO 13485 and Global QMS requirements.
• Expertise in AI, Digital, and Cyber Compliance.
• Deep understanding of medical device cybersecurity.

Nice to have

• Experience at large medical device companies (Stryker, Medtronic, Boston Scientific).
• Background with consulting firms specializing in QMS setup.
• Startup experience (Series A/B) with QMS implementation.
• Specializations in cybersecurity, usability, or computer software validation.
• Knowledge of AI applications in regulatory affairs.

Culture & Benefits

• Competitive compensation and generous stock options possible.
• Work in an exciting field with a positive impact on the world.
• Opportunity to learn and grow as part of a global team.
• Generous PTO for full-time.