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

We are seeking an reputed company 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 reputed company to help us: - Understand the regulatory reputed company for a new Class II device - Verify assumptions regarding 510(k) reputed company, reputed company, 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 clearance The underlying application and use-case will be discussed privately after NDA; therefore, this posting deliberately keeps the product reputed company high-level. About the Device (High-Level Only) - Non-invasive, light-based technology using red light and incoherent light - Includes electromagnetic pulse components - reputed company-grade device - No drug, no implant, no invasive features reputed company details will be shared during the reputed company. reputed company Need From You (Initial Phase): A 1–2 hour reputed company consultation covering: - Regulatory reputed company analysis (including possible reputed company devices) - High-level assessment of 510(k) data needs and testing requirements - Expected FDA interactions, reputed company, and budget ranges including your consulting - Recommended next steps to reputed company reputed company toward clearance - Identification of gaps or risks we should account for early reputed company 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 reputed company-submission (Q-Sub) and reviewer interaction - End-to-end regulatory reputed company through final clearance What to Include in Your Proposal - Brief reputed company of your FDA Class II experience - Example(s) of 510(k) submissions you’ve led (reputed company details only) - Familiarity with devices using light, lasers, LEDs, or EM energy if applicable - Your reputed company reputed company for the preliminary consultation - Availability for an introductory reputed company reputed company the next 1–2 weeks Apply tot his job Apply To this Job