Regulatory Affairs Assistant

Regulatory Affairs AssistantLocation: Raynham, MassachusettsPosition SummaryWe are seeking a detail-oriented and proactive Regulatory Affairs Assistant to join our team in Raynham, MA. The successful candidate will provide critical support in global product registrations, data analysis, and documentation management. The role requires strong analytical skills, notary certification, and the ability to interpret, organize, and visualize data effectively. You will play a key role in ensuring the accuracy and timeliness of regulatory submissions and documentation.Key ResponsibilitiesProvide administrative support for global regulatory submissions, including collecting, analyzing, and summarizing product and registration data.Serve as a Notary Public for the execution of regulatory documents.Work with regulatory databases and document management systems, including MDRIM and Windchill, to retrieve, organize, and maintain documentation.Analyze, interpret, and present data—including creating charts, graphs, and reports to support regulatory strategies and decision-making.Assist with the preparation, tracking, and filing of regulatory documents in compliance with internal and external requirements.Collaborate cross-functionally with Quality, R&D, and other teams to gather necessary data and documentation.Support audits, inspections, and internal reviews by providing accurate and timely document retrieval.Maintain confidentiality and accuracy in handling sensitive information.Participate in continuous improvement of department processes and systems.Required QualificationsNotary Public certification (Massachusetts) or willingness to obtain upon hire.Strong proficiency in data analysis, including the ability to interpret and present complex data sets using charts, graphs, and reports.Proficiency with Microsoft Excel, PowerPoint, and data visualization tools.Excellent organizational and multitasking skills, with strong attention to detail.Effective verbal and written communication skills.Preferred QualificationsExperience with regulatory systems such as MDRIM and Windchill.Familiarity with global medical device registration processes.Bachelor's degree in a scientific, regulatory, or related discipline.