Hire the Best Medical Devices Specialists in Florida

I’m a Family Physician and Clinical Research Associate with over eight years of experience in clinical medicine and research. I’ve worked on international studies with IQVIA, UCSF, and the University of Minnesota, analyzing complex medical charts, study data, and regulatory documents to ensure accuracy, clarity, and compliance with GCP standards. As a Spanish Medical Translator, I specialize in translating medical and clinical research materials from English to Spanish, including informed consent forms, patient-facing materials, regulatory documents, and scientific publications. I also handle general, legal, and technical translations with the same attention to precision and tone. In parallel, I collaborate on AI and data labeling projects, auditing and curating healthcare and scientific datasets, interpreting charts and visual data, and creating structured Q&A pairs to improve reasoning quality and model accuracy. My clinical and linguistic background allows me to combine subject-matter expertise with analytical precision and clear communication. Areas of Expertise: • Healthcare, Clinical Research & Regulatory Review • Medical and Scientific Q&A Creation • Chart, Graph & Data Interpretation • AI/ML Data Labeling and Annotation • English ↔ Spanish Medical Translation • Adverse Event Detection & Narrative Review • Quality Control and Data Integrity Auditing

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.

If you can dream it, I can build it. I have 10 years of experience building websites and apps that make sense to users and revenue for businesses. View my work at Jwm.nyc/products. I can design and build responsive websites using frontend languages (HTML, CSS, JS) or on low-code platforms like WordPress, Shopify, Webflow, Framer, and more. I can integrate payment gateways like Stripe or PayPal, custom APIs such as Printful, and membership systems like Memberstack. Whatever platform you need, I can create a site that offers a great user experience, helps generate profit, and stays under budget.

If you need high-quality writing for your medical or health business, look no further. As a pharmacist by trade, there’s a good chance I’ve personally connected with your audience. As an internationally published medical writer (member of AMWA), I know how to break down complex jargon and make it easy to swallow. I’ve also worked with physicians, nurse practitioners, and other healthcare professionals, so I’m fluent in Doc-speak if you're needing technical writing. No matter who your audience is, I am able to connect with them through carefully crafted content. My core services include: - Medical and health content writing - Medical editing - Medical proofreading - Medical technical writing With so much misinformation and false claims appearing in the medical niche, it’s important that your content is FDA and FTC compliant. My background in research and appraising journal articles will ensure your content's credibility. I am also well-versed in: - SEO content writing - Content marketing - Content strategy These skills work hand-in-hand to make sure you’re meeting the current standards of today’s digital environment. Don’t fight for attention when you can show up and be respected for the value your content brings. Your audience will grow, thank you, and rightly compensate you for it. Invite me to your next project if you want highly researched, engaging content. Or if you just need a medical eye on your copy. Whether it’s for patients, consumers, or physicians, I can take care of it. NOTE: I prefer to work with forward-thinking businesses who know the value of good writing. More points if you know what content strategy and SEO can do for your business.

Most MedTech companies don’t fail because the product doesn’t work. They fail because the go-to-market system wasn’t built for hospital reality. I help MedTech, robotics, and AI-health startups turn FDA clearance into scalable U.S. revenue. I’m a U.S.-based commercialization leader with hands-on experience inside operating rooms, hospital boardrooms, and enterprise sales cycles. I’ve built commercialization engines for surgical, AI, and software-driven healthcare technologies, including serving as the first U.S. commercial hire for an AI-powered neurosurgical platform. I specialize in the “first commercial mile”: The critical phase between regulatory clearance and predictable revenue.

Breaking News: One product we designed in cooperation with our customer, the "8 Degree" pedal just won one of the Time Magazine "Best Inventions of 2024" awards in the "Design" category! Expert in product design, specifically medical products with electro-mechanical content. Experienced plastic part designer. Experience designing for the magnetic resonance imaging(MRI) product environment. Also have experience with medical rehabilitation products. Regulatory compliance experience with FDA GMP, ISO 13485, UL, and CE (MDD). Quality and reliability are my first priority on most projects. Partner in Step 2 Engineering which is a product engineering company near Orlando, Florida. Experience manufacturing in US and China with partners in a variety of disciplines. Diverse interests include motorsports, guitar playing, soccer, programming, electro- mechanical "maker" projects, machining and woodworking.