Clinical Regulatory Associate

The Clinical Regulatory Associate joins the Premarket Regulatory Affairs team and supports U.S. regulatory submissions for Class II and Class III medical devices. In this entry-level role, you contribute to portions of FDA submissions, including 510(k), IDE, and PMA activities, while learning directly from experienced Regulatory Affairs professionals and collaborating with cross-functional teams. This position is ideal for recent graduates or early-career candidates who demonstrate strong academic performance, meticulous attention to detail, and a clear interest in building a long-term career in medical device Regulatory Affairs.

• Support portions of U.S. FDA submissions for Class II and Class III medical devices, including 510(k), IDE, and PMA activities.
• Gather, organize, and maintain documentation required for regulatory submissions, ensuring materials are complete, accurate, and compliant with internal processes.
• Assist with the preparation and formatting of submission documents, following established regulatory and quality procedures.
• Review product labeling and product-change documentation to help ensure consistency with regulatory requirements and internal standards.
• Support regulatory pathway assessments by compiling relevant technical and clinical information and helping to document regulatory strategies.
• Maintain regulatory files and records, including tracking documentation, version control, and archiving submission materials.
• Apply foundational knowledge of FDA requirements, guidance documents, and Title 21 of the Code of Federal Regulations while learning internal regulatory processes.
• Collaborate with senior Regulatory team members, Product Development, Clinical Affairs, and other internal partners to gather information needed for submissions.
• Communicate clearly with cross-functional stakeholders, ask thoughtful questions, and follow up on assigned items to keep submission activities on track.
• Organize detailed information and manage multiple assignments simultaneously while meeting deadlines and quality expectations.
• Follow established documentation and review processes with close attention to detail and a strong focus on accuracy.
• Contribute to labeling reviews, product-change documentation, and quality or design-control related documentation as needed.
• Participate in on-site interviews and ongoing feedback discussions, demonstrating receptiveness to coaching and commitment to continuous learning.

• Demonstrated interest in pursuing a career in Regulatory Affairs, shown through relevant coursework, internships, co-ops, academic projects, research, or early professional experience.
• Approximately 0 to 2 years of relevant experience in Regulatory Affairs, clinical research, clinical science, clinical trials, or clinical development; prior Regulatory Affairs experience is preferred but not required.
• Strong written communication skills for preparing submission documents, reviewing labeling, and handling product documentation.
• Strong verbal communication skills to interact effectively with senior Regulatory team members and cross-functional partners.
• Excellent document review and organizational skills, with the ability to verify completeness and accuracy of technical documentation.
• Ability to follow established regulatory and documentation processes with meticulous attention to detail.
• Ability to organize detailed information and work on multiple assignments simultaneously.
• Capability to work independently while also collaborating effectively with senior team members and cross-functional partners.
• Familiarity with FDA regulations or Title 21 of the Code of Federal Regulations (21 CFR) is preferred.
• Exposure…