Ketryx
QA/RA Consultant
Boston, Massachusetts, United States · Senior · Full-time
Work authorization required$130k-$150kDetected 36 days ago
ComplianceMedical Devices
About the role
- This is a rare opportunity to shape the future of regulatory affairs.
- Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position.
- This position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option).
Responsibilities
- Own and manage QMS templates and regulatory compliance frameworks.
- Scale operations to support high-growth clients.
- Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance.
Requirements
- 4-8 years of experience in quality systems management, management representative or senior specialist role.
- Knowledge of AI applications in regulatory affairs.
Nice to have
- Preferred Skills:
Skills
- 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.
- Proven track record in consulting or client-facing roles.
- 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.
Compensation
- $130,000 - $150,000, plus equity options. (Compensation dependent on experience level)
- 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.
- Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position.
- This position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option).
Benefits
- Generous stock options possible
- Generous PTO for full-time
- Ketryx is saving and improving lives by making medical software safe and reliable.
- We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide.
- We believe that, by automating much of the documentation and quality processes, teams will be able to produce safer and more innovative medical software faster.
- Ketryx is at the forefront of helping teams incorporate AI/ML into medical software and that's why we need you!
- Lead Quality Management System (QMS) setup and deployment for medical device clients.
Company info
- Opportunity to learn and grow as part of a global team
Equal opportunity
- equal opportunity employer.
Visa & Work Authorization
- Applicants must be authorized to work for any employer in the U.S.
This listing is sourced directly from Ketryx's careers page and normalized into a canonical job model.