Spike Neuro is seeking a Regulatory Affairs & Quality Manager to lead the regulatory strategy and testing oversight for a novel neural implant as it advances from the preclinical stage through clinical investigation. This individual will serve as the company's primary point of engagement with the U.S. Food and Drug Administration (FDA) across Pre-Submission (Q-Sub), Investigational Device Exemption (IDE), and 510(k)/De Novo pathways, and will oversee (though not necessarily perform) the bench, biocompatibility, and preclinical testing required to support these submissions. The role is also central to building, implementing, and maintaining Spike Neuro's quality management system. Spike Neuro develops and manufactures electrophysiology and neurochemistry tools including neural probes, surface arrays, and data acquisition hardware, and is actively developing implantable neural interface products. This is a high-ownership role for a regulatory professional who wants to guide a device's full regulatory journey, from early feasibility through clinical entry, within a small, mission-driven company. Working cross-functionally with engineering, preclinical, and clinical teams, and coordinating external testing laboratories and contract research organizations (CROs), the Regulatory Affairs & Quality Manager will translate complex technical work into defensible regulatory submissions. A neuroscience background is preferred but not required; we welcome candidates from across the medical device field who bring strong, relevant regulatory and quality experience. The position offers significant room for growth, including the opportunity to build and lead a regulatory and quality function as the product line matures toward commercialization. Major Responsibilities Develop, own, and maintain the regulatory strategy and submission roadmap for a novel neural implant, from preclinical development through clinical investigation Serve as the primary liaison with the FDA; plan, author, and defend Pre-Submission (Q-Sub) meeting requests, Investigational Device Exemption (IDE) applications, and 510(k)/De Novo submissions Determine the appropriate regulatory pathway, device classification, and testing requirements, and align submission timelines with product development milestones Oversee (but not necessarily perform) the testing required to support FDA submissions, including bench, electrical safety, biocompatibility, sterilization, software, and preclinical (animal) studies Select, coordinate, and manage external testing laboratories, contract research organizations (CROs), and consultants; review test protocols and reports for scientific soundness, standards compliance, and data integrity Ensure testing is planned and executed in accordance with applicable consensus standards and Good Laboratory Practice (GLP) requirements Support the design, implementation, and ongoing maintenance of the company's quality management system, including design controls, risk management, document control, and CAPA Establish and maintain regulatory documentation, including the design history file (DHF), technical files, and submission records Monitor evolving FDA regulations, guidance documents, and consensus standards, and advise leadership on regulatory risk, strategy, and timelines Partner with engineering, preclinical, and clinical teams to ensure that design and testing decisions are submission-ready Support clinical study planning and execution, including IRB engagement and early feasibility study (EFS) infrastructure Prepare the organization for FDA interactions, audits, and inspections Provide clear regulatory updates, risk assessments, and recommendations to senior leadership Minimum Requirements Bachelor's degree in engineering, a life or physical science, or a related technical field 3+ years of experience in regulatory affairs and/or quality within the medical device industry; candidates whose depth of directly relevant experience exceeds this are encouraged to apply regardless of exact title history Working knowledge of the FDA regulatory framework for medical devices, including premarket pathways (Pre-Submission/Q-Sub, IDE, 510(k), and De Novo) Familiarity with medical device testing requirements (such as biocompatibility, electrical safety, and sterilization) and the ability to scope and evaluate test protocols and reports Working understanding of Good Laboratory Practice (GLP) and FDA design control requirements Experience with, or strong working knowledge of, medical device quality management systems (ISO 13485 and/or

FDA 21 CFR

Part 820) Strong technical writing skills, with the ability to author and defend regulatory submissions Excellent reading, writing, and communication skills in the English language Highly organized and detail-oriented, with the ability to manage multiple workstreams and external partners simultaneously Strong problem-solving and cross-functional collaboration skills Self-motivated and able to work independently in a fast-paced, small-company environment Preferred Requirements Advanced degree (M.S. or Ph.D.) in engineering, neuroscience, biomedical science, or a related field Background in neuroscience, neural interfaces, or implantable / active implantable device technology (preferred, not required) Direct experience leading or supporting IDE and clinical-stage programs, and/or Class II (510(k)), Class III (PMA), or De Novo submissions Experience advancing a device from preclinical testing through first-in-human or early feasibility studies (EFS) Hands-on experience implementing, maintaining, or auditing an

ISO 13485

quality management system Familiarity with

ISO 14971

(risk management), ISO 10993 (biocompatibility), IEC 60601 (electrical safety), and

IEC 62304

(software life cycle) Experience selecting and managing CROs, testing laboratories, and regulatory consultants Regulatory Affairs Certification (RAC) or an equivalent credential Prior direct interaction with FDA review divisions Other Role Details Preference for a hybrid schedule with regular in-office presence in the Ann Arbor, MI area; highly qualified remote candidates will also be considered Some travel may be required for FDA meetings, on-site oversight of testing partners, and collaboration visits to partner institutions This role offers significant opportunity for growth, including the potential to build and lead a regulatory and quality team as Spike Neuro's product line advances toward commercialization To Apply When submitting your CV, include a brief summary of the regulatory submissions you have contributed to, noting for each the pathway (e.g., Q-Sub, IDE, 510(k), De Novo, or PMA), the device type and class, and your specific role, along with any quality systems you have helped build or maintain. Strong candidates should expect a discussion of regulatory strategy and testing oversight as part of the interview. Employment Details Spike Neuro is proud to be an equal opportunity workplace and is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. In this position, you will have access to knowledge and information, including but not limited to, technology, methodologies, service capabilities, and products of Spike Neuro and its clients, which is considered proprietary and confidential. By accepting this offer, you agree that such knowledge and information will be used solely for the benefit of Spike Neuro, LLC and its customers or approved partners, and will never be disclosed to competitors or non-approved third parties unless required by law. Spike Neuro, LLC is an E-Verify employer. All employees are employees at will. Nothing in this description constitutes an employment contract.

Pay:

$90,000.00 - $140,000.00 per year

Benefits:

Dental insurance Flexible schedule Health insurance Life insurance Paid time off Parental leave Retirement plan Vision insurance

Work Location:

Hybrid remote in Ann Arbor, MI 48108