Strategist, Regulatory Affairs

📋 Description Manage, plan, prepare, and deliver regulatory documents for global product registrations, renewals Coordinate preparation and submission of medical device applications, addressing queries from Prepare/review letters of authorization, cover letters, declarations, and other regulatory Submit and manage US FDA Certificates to Foreign Government (CFG) applications. Maintain tracking tools to ensure up-to-date regulatory data and document traceability. Coordinate legalization, notarization, and apostille of regulatory documents. 🎯 Requirements Bachelor’s degree (Life Sciences or regulatory-related field preferred). Minimum 1 year of hands-on medical device regulatory affairs experience, or 3 years combined Basic knowledge of US FDA QSR, ISO 13485, EU MDD/MDR. Knowledge of global medical devices registration process considered a plus. Proficient in Microsoft Office (Word, Excel, PowerPoint). Strong written/verbal communication and organizational skills; detail-oriented with the ability to 🎁 Benefits Hybrid (Cincinnati, Ohio) onsite role with address at 4545 Creek Rd, Blue Ash, OH 45242.