Reimbursement & Regulatory Affairs Consultant for Medical Device Co.
Sales & Business Development · Contractor
Ann Arbor, MI, USA
USD 50-50 / hour
Posted on Jul 9, 2026
Axiobionics LLC | Ann Arbor, Michigan | Consulting or Full-Time
About Axiobionics
Axiobionics designs and manufactures wearable functional electrical stimulation (FES/NMES) devices that help people recover movement and independence after stroke, spinal cord injury, traumatic brain injury, and other neurological conditions — including children with cerebral palsy. Our product line, including the BioSleeve, BioShorts, TripleFlex, WalkAide, and the NeuroPro 8i controller, is built on decades of clinical research and real patient outcomes. As we bring innovative new products to market, getting the reimbursement pathway right — coding, coverage, and payer adoption — is just as critical as the engineering itself.
Position Summary
We're looking for a Medical Insurance & Reimbursement Expert to consult on the mechanics, rules, laws, and practices of medical billing, and to bring deep expertise to Axiobionics' reimbursement strategy. This person will lead our path toward CMS coverage and proper coding for our innovative devices, working directly with insurance companies, Medicare Administrative Contractors, and other payers, while also coordinating with FDA-facing regulatory work to ensure our Indications for Use support and align with reimbursement goals.
This role can be structured as an ongoing consulting engagement or a full-time position, depending on the right candidate. What matters most is deep, hands-on experience getting innovative devices coded, covered, and paid.
Key Responsibilities
Reimbursement Strategy & CMS Coding
● Lead strategy for CMS coverage, coding (HCPCS Level II/CPT), and payment determinations across Axiobionics' product line
● Prepare and support HCPCS coding applications and coding verification requests to CMS
● Analyze and apply CMS coverage policies, LCDs/NCDs, and DMEPOS payment methodologies (including capped rental) relevant to our devices
● Develop and refine pricing and coding justification packages for new products and expanded indications
Payer Relations & Insurance Company Interface
● Serve as a primary point of contact with commercial payers, Medicare Administrative Contractors, and state Medicaid programs on coverage and reimbursement matters
● Support prior authorization strategy, appeals, and payer medical policy development
● Build payer-facing comparative cost/value documentation and supporting regulatory memos to drive coverage adoption
FDA & Regulatory Coordination
● Coordinate with FDA-facing regulatory efforts regarding Indications for Use (IFU) expansion and Pre-Submission strategy as they relate to reimbursement pathways
● Ensure regulatory clearances, labeling, and claims align with and support coding and coverage strategy
● Track evolving FDA and CMS policy that could affect device classification, coverage, or payment
Compliance & Documentation
● Ensure billing and reimbursement practices align with applicable healthcare laws and payer contract requirements
● Develop SOPs and internal guidance for billing staff on coding and coverage requirements
● Stay current on evolving healthcare billing regulations, coding updates, and payer policy changes
What You'll Need
● Extensive experience in medical device or DME reimbursement, health policy, or medical billing/coding, including direct experience interacting with CMS
● Deep knowledge of CMS coverage and coding processes: HCPCS Level II coding, DMEPOS payment categories, LCDs/NCDs, and capped rental methodology
● Demonstrated, hands-on experience interfacing directly with insurance companies and payers — commercial and government — on coverage and reimbursement issues
● Experience working with or alongside FDA regulatory processes, particularly as they relate to Indications for Use and how they support reimbursement
● Strong understanding of relevant healthcare law and compliance considerations affecting billing and payer relationships
● Excellent written communication skills for policy memos, coding justification packages, and payer submissions
● Comfortable operating as a strategic advisor within a small, fast-moving medical device company
Nice to Have
● Experience with neurostimulation, FES/NMES, or other durable medical equipment (DME) categories
● Background at a payer organization, Medicare Administrative Contractor, or CMS itself
● Experience with Breakthrough Device Designation and its reimbursement implications
● Existing relationships with payer medical policy committees
What We Offer
● A high-impact strategic role directly shaping how our devices reach and are paid for by patients
● Flexible engagement structure — consulting or full-time — built around the right expertise
● A mission-driven company with a strong clinical evidence base behind its products
Axiobionics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Axiobionics, LLC is an equal opportunity employer.