FDA Regulatory Consultant Needed for Class II Medical Device (Preliminary Advisory Engagement)

We are seeking an experienced FDA regulatory consultant with deep expertise in Class II medical devices - particularly those involving light-based technologies (e.g., red light/photobiomodulation) and electromagnetic pulse components. This initial engagement will be a preliminary consulting call to help us: - Understand the regulatory pathway for a new Class II device - Verify assumptions regarding 510(k) strategy, timeline, and bolthires - Evaluate the regulatory requirements for our device architecture - Determine scope and readiness for a full 510(k) submission - Establish whether you might serve as our long-term regulatory advisor through submission and FDA clearance The underlying application and use-case will be discussed privately after NDA; therefore, this posting deliberately keeps the product description high-level. About the Device (High-Level Only) - Non-invasive, light-based technology using red light and incoherent light - Includes electromagnetic pulse components - Professional-grade device - No drug, no implant, no invasive features Further details will be shared during the call. What We Need From You (Initial Phase): A 1–2 hour paid consultation covering: - Regulatory pathway analysis (including possible predicate devices) - High-level assessment of 510(k) data needs and testing requirements - Expected FDA interactions, timeline, and budget ranges including your consulting - Recommended next steps to move efficiently toward clearance - Identification of gaps or risks we should account for early Future Scope (Optional, Not Required for Initial Engagement) Based on the outcome of the preliminary consultation, we may expand the engagement to: - Full 510(k) project management and authoring - FDA pre-submission (Q-Sub) and reviewer interaction - End-to-end regulatory strategy through final clearance What to Include in Your Proposal - Brief overview of your FDA Class II experience - Example(s) of 510(k) submissions you’ve led (public details only) - Familiarity with devices using light, lasers, LEDs, or EM energy if applicable - Your hourly rate for the preliminary consultation - Availability for an introductory call within the next 1–2 weeks Apply tot his job Apply tot his job