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Blackrock Neurotech innovative brain technologies provide new hope for people with paralysis & other neurological disorders.

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Blackrock Neurotech is a team of the world’s leading engineers, neuroscientists, and visionaries. Our mission is simple: We want people with neurological disorders to walk, talk, see, hear, and feel again. We’re engineering the next generation of neural implants, including implantable brain-computer interface technology that restores function and independence to individuals with neurological disorders. Join us in changing lives today.Connect with us: Join Our Team | https://bit.ly/3bCsXRv LinkedIn | https://bit.ly/3PfifOL Twitter | https://bit.ly/3PfifOL Instagram | https://bit.ly/3bMaYrW Facebook | https://bit.ly/3JRc2avClinical Trials | https://bit.ly/3A8QPWmOur site | https://blackrockneurotech.comAdditional information: As the world leader in BCI tech, our pioneering neuroscience tools push the boundaries of research and empower innovation across more than 500+ global institutional partners, restoring function in patients suffering from neurological disease (ALS, Alzheimer’s, Parkinson’s), dysfunction (epilepsy, pain, brain trauma), and paralysis disorders. Our systems can be optimized from the ground up to handle even the most challenging applications. Our BCI is the most sophisticated and long-tested human BCI, interfacing with the brain and empowering independence in those with paralysis & other neurological disorders since 2004. In fact, dozens of patients have used our BCI for a collective 30,000+ days to regain freedom through movement and communication. Our first commercial BCI, MoveAgain, received a Breakthrough Designation from the FDA in 2021 and is expected to be commercially available in 2023. Join us in changing lives today.

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MindX, acquired by Blackrock Neurotech, is an innovative brand that offers cutting-edge brain technologies for individuals with paralysis and other neurological disorders. Committed to radically improving human lives, MindX is a diverse team of talented individuals dedicated to engineering the future. Their flagship product, the MoveAgain BCI System, is designed for clinical use and provides patients with greater independence. Additionally, MindX's groundbreaking BCI technology is showcased in the BCI Exhibit in Washington D.C., where art created using their technology is featured. MindX envisions a future where their neurotechnology platform, developed by leading engineers, neuroscientists, and visionaries, positively impacts patients' lives. With over 19 years of human studies, 30,000 days of implant research, and collaborations with over 1,000 research institutions, MindX's breakthrough technologies offer new hope for those with paralysis and neurological disorders. Through their brain tech, individuals have been able to perform various tasks, such as brain typing at an impressive speed of up to 90 characters per minute with 94% accuracy. MindX's BCI pioneers, like Matt, Jan, Nathan, and Ian, have experienced restored function and achieved remarkable accomplishments using their implantable brain-computer interfaces. MindX's technology is trusted by leading institutions worldwide, with over 1,000 labs equipped with their neurotechnology devices. Stay up-to-date with their latest breakthroughs, news, and exclusive events by signing up for their newsletter. MindX is paving the way for a future where individuals can regain independence and explore endless possibilities through the power of thought.

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### **Build the systems that expand human capability**

At Blackrock Neurotech, we've spent decades making the impossible possible – helping people move, speak, and reconnect with the world when they otherwise could not. We've seen that restoring function restores more than ability. It restores independence, identity, and agency.

Today, we are building the next generation of human capability: brain-computer interfaces that are designed to be safe, scalable, and trusted in the real world. Our work is not only about reconnecting people to what was lost, but about expanding what is possible – creating a seamless interface between human intent and technology.

This is foundational work in a category-defining field. You will help build the infrastructure for a future where neural interfaces are invisible, reliable, and deeply human-centered.

##### **Working at Blackrock Neurotech means:**

- Owning meaningful, high-impact problems at the frontier of science and engineering
- Building alongside experienced, thoughtful peers across disciplines
- Solving technically complex challenges grounded in real human outcomes
- Contributing to a culture that values rigor, clarity, and long-term thinking over noise

#### How We Work

We are a small, experienced team working on consequential problems.

- We take ownership of outcomes and follow through with clarity and accountability
- We prioritize sustained, high-quality work over performative urgency
- We value rigor, sound judgement and thoughtful decision-making
- We collaborate deliberately: low ego, high trust and high context

_This is a high-ownership role, but it is not an "always-on" one. We expect strong work and our people to have a life outside of it._

#### **The Role**

Blackrock Neurotech is seeking a Contract Senior Regulatory Affairs Specialist to provide hands-on regulatory support across our medical device programs. This is a part-time/fractional opportunity, expected to require up to 25 hours per week, with flexibility based on business needs. In this role, you'll evaluate product and labeling changes, support audit activities, and help develop procedures within our existing quality management system.

You'll bring strong working knowledge of ISO 13485 and ISO 14971, sound regulatory judgment, and the ability to independently move work forward. Experience developing quality system processes for clinical trial sponsorship would be particularly valuable as we build out this capability.

#### **What You'll Do**

- Prepare standard operating procedures and work instructions and integrate them into Blackrock's existing quality management system
- Evaluate product changes to determine their regulatory impact on existing device clearances and document the assessment and rationale
- Provide regulatory guidance and deliverables for device development projects
- Support sterilization audits, cleanroom audits and inspections, and internal audits
- Review labeling changes and associated deviations for regulatory impact and alignment with applicable requirements
- Partner with Regulatory, Quality, Clinical, and Engineering colleagues to resolve questions and complete assigned deliverables

#### **What You Bring**

- Senior-level regulatory affairs experience within the medical device industry, with the ability to independently assess issues and provide practical guidance
- Strong working knowledge and demonstrated application of ISO 13485 and ISO 14971
- Experience evaluating device changes for regulatory impact, including effects on existing clearances
- Experience drafting and maintaining SOPs, work instructions, and other controlled documents within an established quality management system
- Familiarity with audit support, labeling review, and deviation processes
- Strong technical writing, attention to detail, and the ability to manage multiple priorities and meet project deadlines

**Contract Details:**

- **Location:** Remote, with travel to Blackrock Neurotech's headquarters in Salt Lake City, Utah, as needed
- **Engagement:** Fractional, part-time contract
- **Duration:** Approximately 3 months

Sr. HR Business Partner at Blackrock Neurotech

Maria Valenzuela

Senior Manager, HR

Senior HR Manager at Blackrock Neurotech

Jessica Newman

HR Manager

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Celine Emilie

Operations Manager

Senior Regulatory Affairs Specialist, Consultant (Contract, part-time

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Regulatory Affairs

Medical Device

Quality Management

Blackrock Neurotech is seeking a Fractional Senior Regulatory Affairs Specialist to provide regulatory support for medical device programs. This part-time role requires up to 25 hours per week, focusing on product evaluation, audit support, and quality management system development.

Fractional Senior Regulatory Affairs Specialist

Blackrock Neurotech

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Fractional Senior Regulatory Affairs Specialist

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