Blake Molinaro

Medical device regulatory professional with ten years of experience in complaint handling, registrations, and product approvals both domestic and international. Successfully obtained product approval for a portfolio of medical device products in dozens of countries, then maintained these approvals and ensured compliance across renewals, periodic audits, regulatory framework updates, and business changes. Facilitated over a dozen US FDA submissions and filings, including successful 510(k) submissions for new devices and major product revisions. Helped build a portfolio of approved, legally marketed devices with a competitive global presence, which achieved startup acquisition.