Hiring: Regulatory Affairs Specialist Company: EPM Scientific Location: Los Angeles County, CA Job Posted Time: 2026-09-12 13:52:14 Employment Type: Remote About the job Experience: •2 to 5 years of Regulatory Affairs or related medical device industry experience. •Comprehensive benefits package and professional development opportunities available. Required Skills: •Support development activities for medical device software products. •Develop regulatory strategies and prepare submissions for markets including the United States, European Union, and Canada. •Partner cross-functionally 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. •Strong technical writing, editing, analytical, and problem-solving skills. •Demonstrated capacity 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. •Bachelor's degree required. Compensation: •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!