AI Native QA/RA Lead

Ketryx•Boston, MA

62d•$130,000 - $150,000•Hybrid

About The Position

As a Ketryx AI Native QA/RA Lead, you will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. You'll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future of regulatory affairs through innovative technology and enabling the success of the world’s most innovative companies. We offer the opportunity to work with high-growth clients, establishing best-in-class quality systems from the ground up using our revolutionary AI platform. Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position. In this role, you'll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life-saving medical devices. This position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). 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. About You: You're a proven QMS expert who's successfully navigated complex medical device regulatory landscapes and is ready to scale your impact through innovative technology. You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered tools to create something category-defining.

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
Experience as quality management representative in regulated environments
Experience with regulatory and Notified Body submission requirements
Background in medical device industry quality systems
Ability to work independently and own complex regulatory projects
Proven track record in consulting or client-facing roles

Nice To Haves

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
Experience scaling quality operations in high-growth environments
Knowledge of AI applications in regulatory affairs
Submission experience

Responsibilities

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
Shape the future of regulatory affairs through innovative product development
Work independently on complex quality assurance projects requiring minimal oversight
Ensure customer success across entire the entire customer engagement lifecycle