Senior Regulatory Affairs Specialist

Lumicity - Pennsylvania, United States

Hiring: Senior Regulatory Affairs Specialist Company: Lumicity Location: Pennsylvania, United States Job Posted Time: 2026-09-16 12:30:33 Target Skills & Keywords : Product Development Lifecycle, Project Management About the job Experience: •5+ years of Regulatory Affairs experience within medical devices •Applied hands-on capability in FDA regulatory submissions •In-depth knowledge of medical device regulations and Design Controls •Strong communication, organization, and project management skills •If you're looking for an opportunity to take on meaningful regulatory responsibility while helping advance innovative medical technologies, we'd encourage you to apply. Required Skills: •Support regulatory activities throughout the product development lifecycle •Develop and execute regulatory plans for medical device products •Prepare regulatory documentation and support product submissions •Provide regulatory guidance to cross-functional teams •Support U.S. and international market activities •Partner cross-functionally with internal teams to ensure regulatory requirements are met •Maintain regulatory documentation and support ongoing product compliance Qualifications: •Bachelor's degree in a scientific, engineering, or related discipline Compensation: •$110,000 - $130,000 / year 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!