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 cost- 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 clearanceThe 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 featuresFurther 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 earlyFuture 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 clearanceWhat to Include inYour 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