Regulatory Affairs Associate

Company Description MED-ALLY specializes in the design, development, and manufacturing of implantable medical device systems for the global market, including neuromodulation, bioelectronic, deep brain stimulation, and neurostimulation devices. With innovative solutions like the VersaStim® 16+ channel platform system, we help accelerate neuromodulation and bioelectronic projects to commercial launch, offering customizable therapeutic solutions that save time and cost. At MED-ALLY, we are committed to advancing healthcare through cutting-edge technology and collaboration with our partners. Role Description This is a full-time, on-site role located in Moncks Corner, SC, for a Regulatory Affairs Associate. The associate will be responsible for preparing, reviewing, and submitting regulatory documents in compliance with relevant guidelines. Key day-to-day tasks include ensuring adherence to regulatory compliance, interpreting and implementing regulatory requirements, supporting the development of submissions for FDA and other regulatory agencies, and maintaining up-to-date knowledge of industry standards and best practices. Coordination with cross-functional teams and preparing detailed regulatory reports are also key components of the role. Qualifications Proficiency in creating, reviewing, and managing Regulatory Documentation and SubmissionsStrong knowledge of Regulatory Compliance and Regulatory RequirementsExperience in Regulatory Affairs, including processes related to FDA and other international regulatory bodiesStrong organizational, analytical, and communication skillsAttention to detail and ability to handle multiple projects and deadlines effectivelyBachelor's degree in a related field such as Life Sciences, Engineering, or equivalent experiencePrevious experience working with medical devices or in the healthcare industry is a plus