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.