Associate Regulatory Writer & 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 an Entry-Level Regulatory Writer and Project Manager. 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 responsibility will be supporting the development and FDA submission of Software as a Medical Device (SaMD) products. 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 🔗
- Support the creation of high-quality FDA regulatory documentation (e.g., Software Descriptions, Requirements Traceability, Risk Analyses, and Validation Plans).
- Help keep projects on track by monitoring timelines, managing task boards, and coordinating with clients and internal stakeholders.
- Learn and apply FDA guidance documents and relevant standards (e.g., IEC 62304, ISO 14971) under supervision. Here are some example guidance documents that you will become familiar with.
- Collaborate with engineers, clinicians, and regulatory consultants to clarify requirements, user needs, intended use, and indications for use. Read more about this here.
- Actively participate in client meetings and document takeaways into actionable tasks.
- Use Notion (our primary tool for project management and documentation) to stay organized and aligned with the team.
What We’re Looking For 🔗
- Degree in biomedical engineering or a related field.
- 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.
- Excellent attention to detail and strong organizational skills.
- Clear, concise writing skills—especially for technical or scientific content.
- A comfort with ambiguity and a knack for structuring messy information.
- Interest in healthcare, medical technology, and/or regulatory science.
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 ($70,000 – $80,000) 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, after this, it drops down to 40 hours/week. We expect associates to be promoted within 2 years of joining.
How to Apply 🔗
Please email utbmeapply@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. Our technical interview process involves a “take home” project where you’ll write some documentation for a made-up medical device. We’ll then discuss and critique your documentation on a call.
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.
