Regulatory Affairs Associate

Prepare, author, and submit U.S. FDA PMA supplements, including: 30-Day Notices Real-Time Reviews 180-Day Supplements Annual Reports Support updates to EU MDR Technical Documentation and prepare documentation for Notified Body submissions. Conduct regulatory assessments for manufacturing, design, and process changes to determine FDA and EU MDR regulatory impact. Review and approve engineering study protocols and reports. Review and approve validation study protocols and reports. Collaborate with Engineering, Quality, Manufacturing, R&D, and other cross-functional teams to support regulatory submissions and product changes. Support interactions with U.S. and international regulatory authorities as needed. Ensure regulatory submissions and documentation are accurate, complete, and compliant with applicable regulations. Maintain current knowledge of FDA regulations, PMA guidance documents, and EU MDR requirements. Track submission timelines and ensure deliverables are completed on schedule. Support regulatory compliance activities throughout the product lifecycle. Perform additional regulatory projects and duties as assigned. Qualifications Bachelor's degree in Biology, Engineering, Chemistry, Regulatory Affairs, or another related scientific discipline. Minimum of 1 year of direct Regulatory Affairs experience within the medical device industry. Working knowledge of FDA PMA regulations, guidance documents, and 21 CFR requirements. Familiarity with EU MDR (2017/745) regulatory requirements. Strong technical writing, documentation, and organizational skills. Ability to review technical documentation and assess regulatory impact. Strong communication and cross-functional collaboration skills. Ability to manage multiple projects while meeting regulatory deadlines. Proficiency with Microsoft Office applications. Preferred Experience authoring or supporting FDA PMA supplements. Experience with EU MDR Technical Documentation updates and Notified Body submissions. Knowledge of FDA design control, validation, and change control processes. Experience working in a highly regulated medical device environment. Familiarity with global regulatory submissions and product lifecycle management. #J-18808-Ljbffr