Regulatory Affairs Specialist

Regulatory Affairs Specialist Responsibilities Support development activities for medical device software products.Develop regulatory strategies and prepare submissions for markets including the United States, European Union, and Canada.Collaborate with regional regulatory teams to align global regulatory strategies.Review and approve product labeling and promotional materials for software products.Represent Regulatory Affairs on cross-functional software development teams.Review and approve software documentation and determine regulatory submission requirements.Support additional regulatory projects and initiatives as needed. Qualifications Knowledge of U.S. and international medical device regulations, including design controls, submission requirements, labeling regulations, promotional requirements, and quality systems.Experience with medical device software and understanding of software development lifecycle processes, IEC 62304, and software classification.Strong technical writing, editing, analytical, and problem-solving skills.Ability to work independently while collaborating effectively with cross-functional teams.Comfortable operating in a fast-paced environment with changing priorities.Strong organizational and communication skills.Experience with 510(k) submissions, Health Canada submissions, and/or EU MDR is preferred. Education & Experience Bachelor's degree required.2 to 5 years of Regulatory Affairs or related medical device industry experience. Additional Information Remote/home office-based role.Approximately 5-15% travel required.Comprehensive benefits package and professional development opportunities available.