Careers · Open Role
Clinical & Quality Operations Lead
Neurotype Inc. · Upper Midwest (Minnesota / Western WI) · Hybrid with periodic in-person work
About Neurotype
Neurotype Inc. is a Minnesota-based medical device startup developing NeuromarkR™, an investigational EEG-based clinical decision support tool designed to give clinicians an objective window into a patient's craving and cue reactivity during opioid use disorder treatment. We're NIH-funded (SBIR Phase II) and on a De Novo pathway toward FDA Class II authorization. The science is real, the clinical need is urgent, and we're building the infrastructure to prove it.
The Role
We're hiring our first Clinical & Quality Operations Lead, a hybrid role at the intersection of clinical trial oversight and quality system infrastructure. You'll work directly with the CEO/PI to get our pivotal trial operational and keep our regulatory documentation on track for FDA submission. This is a sponsor-side role centered on sites, IRB processes, and the quality systems that underpin our anticipated De Novo filing. You may occasionally be in contact with participants, for example to help coordinate a follow-up, but recruiting and treating patients is the sites' work, not yours. If you've spent time on the site side and want to move upstream, or if you've done quality work in medtech and want more clinical exposure, this is that job.
This is not a passive coordinator role. We want someone who spots problems early, proposes the fix, and takes ownership of the systems that keep the trial and our regulatory records on track. As our first dedicated clinical and quality hire, you would help build that backbone at an early but real company (NIH-funded, founder-led, and in ongoing dialogue with the FDA), with room to grow as we do.
Location
This is a regional role across the Upper Midwest, centered on Minnesota and western Wisconsin. Strong candidates may be based in Minneapolis–Saint Paul, Duluth/Superior, Rochester, St. Cloud, Eau Claire, or another nearby regional hub.
Minnesota sits at the center of a deep medical-technology and clinical-research ecosystem (the “Medical Alley”). Our founder base is split between Duluth/Superior and the Twin Cities. We are open to candidates across Minnesota and western Wisconsin.
The role is hybrid. Remote arrangements are possible, but expect periodic in-person work and travel tied to our clinical, research, quality, regulatory, device, and partner needs, so it is not a fully remote position.
What You'll Own in Year 1
- IRB and protocol coordination: amendments, renewals, and correspondence under a single-IRB (sIRB) model
- Site activation: get clinical sites stood up and enrolling for a blinded pivotal randomized-controlled trial (~200 participants overall)
- Trial operations: coordinate data collection, toxicology scheduling, and the 12-month follow-up that feeds our primary endpoint
- Safety event tracking: adverse-event monitoring and reporting on the timelines our safety plan and NIH require
- eQMS implementation: help stand up and maintain our electronic quality management system
- Device documentation: versioning, change control, and Design History File entries as the software evolves (IEC 62304)
- Milestone tracking: keep grant progress reporting accurate and ahead of deadlines
Our Work Environment
We take version control and document tracking seriously. Our protocols and regulatory documentation are managed with real change history and structured review. We also use AI agents to help audit and cross-reference our documents, catching version mismatches and protocol inconsistencies before they reach a reviewer, and keeping our regulatory records traceable. This is a genuine learning opportunity: you'll get to work this way and grow with us as the field of AI evolves. If careful, traceable documentation reads as a relief rather than a chore, you'll fit here.
Who You Are
- 3–7 years in clinical research operations, regulatory affairs, or quality, ideally in medical devices or Software as a Medical Device (SaMD)
- Sponsor-side or CRO experience strongly preferred; you've worked at the sites-and-data level more than direct patient care
- Familiarity with eQMS systems, ISO 13485, IEC 62304, or 21 CFR Part 11 a meaningful plus
- Comfortable in early-stage environments where the role evolves with the company
- Tech-enhanced mindset: you favor automated workflows over manual ones, can configure AI tools to strengthen documentation governance, and check their outputs carefully rather than trusting them blindly. Experience with Git/GitHub or other coding and programming is a plus
- Based in Minnesota or western Wisconsin, or another nearby Upper Midwest hub, and able to be on-site periodically as the work requires (see Location above)
Compensation
$68,000–$92,000 depending on experience, with equity eligibility on a vesting basis. This is an NIH grant-funded position; continued funding is contingent on milestone achievement and NIH support at each renewal.
To Apply
Send a short note (one paragraph is plenty) about why this role fits where you are right now, along with your resume, to scott@neurotype.io. Applications are reviewed on a rolling basis.
Neurotype Inc. is an equal opportunity employer. We are committed to building a team that reflects the diversity of the communities our work serves.
