Regulatory Affairs Specialist

Role Overview

• Support the operational execution and maintenance of regulatory activities across the product lifecycle, including pre‑market and post‑market regulatory operations.
• Coordinate and support regulatory submissions and registrations by compiling, formatting, publishing, and submitting regulatory documentation in accordance with applicable regulatory requirements and internal procedures.
• Perform regulatory publishing activities, including preparation and submission of electronic submissions (eSTAR, eCopy, and other electronic formats), ensuring technical compliance and completeness.
• Control, maintain, and archive regulatory records to ensure accuracy, traceability, and inspection readiness.
• Manage and maintain regulatory data within regulatory information management (RIM) and related systems, ensuring data integrity and alignment with regulatory activities.
• Support implementation, configuration, validation, and ongoing administration of regulatory systems and tools, including participation in system enhancements and process improvements.
• Coordinate regulatory workflows and routing processes to support document review, approval, and traceability.
• Support state licensing and renewal activities by preparing, submitting, and maintaining licensing applications and associated documentation.
• Maintain facility registrations and listings with regulatory authorities, including updates related to new, modified, or existing facilities.
• Support UDI management activities, including coordination of device identifiers, database updates, and alignment with labeling and regulatory records.
• Coordinate and track regulatory contracts and agreements, including execution status, renewals, and associated documentation.
• Collaborate with global Regulatory Affairs, Quality, Labeling, Legal, and cross‑functional partners to ensure regulatory operational activities are executed accurately and efficiently.

Requirements

• Bachelor’s degree in Physical or Life Sciences; or a High School Diploma/ General Education Degree (GED) and 4 years of relevant career experience in lieu of Bachelor’s degree
• 2+ years relevant experience in a regulated pharmaceutical or medical device environment
• Basic computer skills to include Internet navigation, Email usage, and word processing
• Proficient in Microsoft Office
• Authorization to work in the United States without sponsorship
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation

Benefits

• paid time off (including days for vacation, holidays, volunteering, and personal time)
• paid leave for parents and caregivers
• a retirement savings plan
• wellness support
• health benefits including medical, prescription drug, dental, and vision coverage