Associate QA/RA Consultant & Project Manager 🔗
Location: Remote (U.S. only)
Job Type: Full-time
About Us 🔗
Innolitics LLC is a remote-only professional services firm. We help other companies build medical device software through three core service areas:
- Software development
- FDA regulatory consulting
- Cybersecurity
We are a growing, collaborative team that values clear thinking, attention to detail, and continuous improvement.
If you’re excited by the intersection of technology, medicine, and regulation—and enjoy organizing and clarifying complex information—you’ll feel at home here.
About the Role 🔗
We're hiring a Mid-Level QA/RA Consultant. In this hybrid role, you'll combine technical writing, project coordination, and quality management while working closely with clients and our internal team. Your primary responsibilities in this role will be support the completion of FDA submission of Software as a Medical Device (SaMD) products and implementing Quality Management Systems for our clients. Recent client projects include:
- AI-powered tools that monitor cancer progression from CT scans
- A sensor and software system for monitoring shunt flow in pediatric patients
- An IVD capable of detecting cancer from blood samples
- Opportunistic screening tools using CT scans
- Software that cross-checks radiation oncology treatment plans
This position is fully remote, with 2-3 trips per year to visit clients and attend our annual company retreat.
What You’ll Do 🔗
- Develop regulatory strategies and conduct pathway assessments (510(k), De Novo, PMA), intended use scoping, predicate analysis, and clinical study design. Deliver clear, actionable regulatory strategy reports that become the roadmap for the entire engagement.
- Prepare and submit Breakthrough Device Designation (BDD) applications.
- Draft Pre-Submission request packages, prepare client teams for meetings, lead the FDA interaction, and translate feedback into next steps.
- Support the creation of high-quality FDA regulatory documentation including Software Descriptions, Clinical Validation Plans, Algorithm Change Protocols, PCCP documentation, and complete 510(k)/De Novo submission packages.
- Advise clients on FDA's AI/ML framework including Good Machine Learning Practice (GMLP), predetermined change control plans (PCCP), and real-world performance monitoring.
- Design clinical validation approaches including standalone performance testing, MRMC reader studies, and equivalence analyses.
- Run client meetings, set agendas, and translate regulatory complexity into clear action items for both technical and executive audiences.
- Help keep projects on track by monitoring timelines, managing task boards, and coordinating with clients and internal stakeholders.
- Use Notion (our primary tool for project management and documentation) to stay organized and aligned with the team.
- Guide Quality Management System implementation for client companies.
- Maintain client relationships and provide ongoing QMS implementation and audit support.
What We’re Looking For 🔗
- Degree in biomedical engineering or a related field.
- FDA submission knowledge required, demonstrated experience with pre-sub, breakthrough, and/or submissions is a strong plus.
- We typically look for applicants with an overall GPA of 3.5 or higher, though we consider the full application and may make exceptions based on other strengths.
- Hands-on experience implementing ISO 13485 and FDA-compliant Quality Management Systems is a beneficial, but not required.
- Excellent attention to detail and strong organizational skills.
What We Offer 🔗
- Mentorship and detailed feedback from experienced regulatory and software professionals. You’ll work hard, but you’ll learn rapidly and gain experience from multiple diverse projects. After the first two years at Innolitics, you’ll have a strong understanding of how real medical device software is developed, validated, and brought onto the market.
- Competitive base salary depending on experience
- 10% performance-based bonus
- Fully remote work with flexible hours
- Partial healthcare reimbursement and automatic 3% contribution to a 401(k) retirement plan
- Annual company retreat for team building and collaboration
- We expect associates to work 45 hours/week during your first year. We expect associates to be promoted within 2 years of joining.
How to Apply 🔗
Please email info@innolitics.com your resume, including your overall GPA, and a cover letter (3–4 short paragraphs) explaining why this role interests you and why you’re a good fit. Also please explain your level of familiarity with software development. Please add the name of this job ad in the subject (Associate QA/RA Consultant).
We are hiring as soon as we find the right person—so don't hesitate to apply! If selected to move forward, you'll hear from our team within 2–3 business days.
