Jodi H.

I am a Regulatory and Quality Consultant with expansive regulatory and quality experience with medical devices, OTC drugs, supplements, cosmetic products and surface cleaners. Over the last 20 years I've held various senior and executive level management positions within FDA and EPA governed companies. I started my career as an Environmental Analytical Chemist and I held my most recent position for 9 years as QA/RA Director for a Henry Schein specialty company, Ortho Technology, a worldwide distributor of orthodontic medical devices. I would love to help you get your new product to the market, as I have experience in regulatory requirements in over 50 countries! Some of my other specialties include technical writing to include SOPs (standard operating procedures), white papers, product submissions/dossiers, Organizational SOP writing (for any type of business), Overall Quality Management Systems that comply with ISO standards and various worldwide regulatory entities. I am well versed with FDA compliant advertising and can assist you with your device and drug label development and/or editing to ensure you are compliant to your jurisdiction. All of these skills require research, so yes, I am really good at that too! My forte and favorite thing is label compliance review! I can review your device, OTC drug, supplement, food, and cosmetic labels for compliance to US FDA, EU Directives, Health Canada and more! Check out my linked in profile for links to a few of the regulatory articles I have written recently. You can also search my name on the FDA website to find 510(k) evidence and other regulatory compliant reports that I have written and submitted.