Clinical Regulatory Associate

About the role

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.

Responsibilities

• 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.

Skills

• 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.
• Cap