Regulatory Affairs Specialist

Regulatory Affairs Specialist Location: Various (not specified). Employment type: Full‑time. This role supports global regulatory submissions and ensures compliance across pharmaceutical and medical device products. Responsibilities Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Coordinate and prepare regulatory submissions, including 510(k) submissions for medical devices. Support the company’s medical device compliance activities, regulatory documentation, and quality system requirements. Ensure submissions and ongoing regulatory compliance for product development and sustaining engineering projects. Determine international regulatory submission and approval requirements. Compile, prepare, and review regulatory submissions with in‑country representatives and ensure timely submission to relevant authorities. Oversee regulatory compliance throughout the product lifecycle, from development and registration to post‑market surveillance. Qualifications Bachelor’s degree in Business, Logistics, Natural Sciences, Chemistry, Engineering, or a related field (preferred). Minimum 1+ year of experience in regulatory affairs, compliance, logistics, or document control. Proficiency in Microsoft Office (Word, Excel, PowerPoint) and Google Sheets. Strong written and verbal communication skills. Knowledge of relevant federal and state statutes and regulations (e.g., pesticide registration, medical device regulations) is advantageous. #J-18808-Ljbffr