Quality and Regulatory Affairs (QA/RA) Lead
About Moberg Analytics
Moberg Analytics is a medical device company focused on bringing advanced brain monitoring and precision medicine to critically-ill patients worldwide. Our flagship product, the Moberg Clinical Platform (MCP), is a next-generation informatics system used in neurocritical care units to integrate data from multiple devices, visualize complex brain signals, and power AI-driven decision support. Developed with over $8M in federal funding and now entering commercialization, MCP represents the cutting edge of Software as a Medical Device (SaMD) innovation.
Position Overview
We are seeking a QA/RA Lead to lead and expand our quality and regulatory activities as we prepare for FDA 510(k) submission and global market expansion. In this position you will take ownership of our Quality Management System (QMS) and regulatory documentation, ensuring compliance with 21 CFR 820, ISO 13485, and ISO 14971, while supporting ongoing product development and post-market processes.
You’ll work closely with leadership, engineering, and clinical partners to operationalize compliance in a rapidly growing organization—and help build the foundation for our next generation of FDA-cleared SaMD products.
Key Responsibilities
Regulatory Affairs
- Lead regulatory strategy and submission planning for an in progress FDA 510(k) and a future EU MDR Class IIa filing.
- Support verification and validation activities, risk management, and usability/human factors testing.
- Develop and maintain device labeling, indications for use, and technical documentation for domestic and international submissions.
- Interface with consultants, notified bodies, and regulatory agencies as needed.
Quality Management
- Maintain and continuously improve Moberg’s 21 CFR 820-compliant QMS, including document control, CAPA, nonconformance handling, internal audits, supplier management, and training records.
- Collaborate with engineering to ensure software development follows IEC 62304 principles for medical software and cybersecurity.
- Prepare and review design history files (DHF), device master records (DMR), and technical documentation.
Cross-Functional Collaboration
- Partner with leadership to ensure company-wide compliance readiness and audit preparedness.
- Guide cross-functional teams on quality and regulatory best practices.
- Contribute to training, SOP development, and internal communication of compliance priorities.
Qualifications
Required
- Bachelor’s degree in engineering, life sciences, regulatory affairs, or a related field.
- 3–7 years of experience in QA/RA for medical devices or SaMD.
- Experience with FDA 510(k) submissions, ISO 13485-compliant Quality Management Systems, and ISO 14971 risk management.
- Excellent communication and documentation skills.
- Ability to work cross-functionally in a small, fast-paced startup environment.
Preferred
- Experience with IEC 62304 (software lifecycle) and IEC 62366 (usability engineering)
- Experience with AI/ML-enabled devices and clinical decision support software.
- Experience with QMS adoption and auditing
- Familiarity with Atlassian products, such as Confluence, Jira, and Bitbucket
- Familiarity with DoD or NIH-funded medical research programs.
Why Join Us
- Shape the regulatory and quality foundation of a fast-growing medical software company.
- Collaborate directly with clinicians, engineers, and AI researchers improving care for critically ill patients.
- Join a mission-driven, innovation-focused team with major academic and defense partnerships.
- A competitive compensation package, including equity participation, health benefits, 401(k), flexible hybrid/remote work, and long-term growth opportunities.
To Apply
Send your resume and a short cover letter to info@moberganaiytics.com with the subject line “QA/RA Lead Application.”