Regulatory Affairs Specialist

Regulatory Affairs Specialist Springfield, IL – Long Term Position Overview We are seeking a detail‑oriented and experienced Regulatory Affairs Specialist to support regulatory compliance activities for medical device products. The role involves preparing regulatory submissions, maintaining product registrations, ensuring compliance with FDA and international regulations, and collaborating with cross‑functional teams throughout the product lifecycle. Key Responsibilities Prepare, review, and submit regulatory documents for product registrations, renewals, and amendments. Support FDA submissions including 510(k), Technical Files, and other regulatory filings as required. Ensure compliance with FDA, ISO 13485, MDR, and other applicable medical device regulations. Maintain regulatory documentation and product registration records. Monitor and interpret changes in regulatory requirements and communicate impacts to internal teams. Collaborate with Quality, R&D, Manufacturing, and Clinical teams to support product development and commercialization. Assist with audits, inspections, and responses to regulatory authorities. Support labelling reviews and regulatory assessments for product changes. Required Qualifications Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field. 2+ years of experience in Regulatory Affairs within the Medical Device industry. Knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and global regulatory requirements. Experience preparing and managing regulatory submissions. Strong documentation, analytical, and organizational skills. Excellent written and verbal communication abilities. Proficiency with Microsoft Office and regulatory document management systems. #J-18808-Ljbffr