A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
On-Site The Regulatory Affairs Specialist is responsible for supporting global regulatory compliance, product registrations, and lifecycle management activities for medical devices and related products. This role works cross-functionally with engineering, quality, operations, marketing, and manufacturing teams to execute regulatory strategies, ensure ongoing compliance with domestic and international regulations, and support successful product commercialization. The Regulatory Affairs Specialist participates in regulatory submissions, change management, product registrations, technical documentation, and post-market regulatory activities while maintaining compliance with FDA, ISO, and international regulatory requirements. Required Education/Experience Bachelor's degree with 3+ years of progressive Regulatory Affairs experience within the medical device, or pharmaceutical industry. Working knowledge of FDA medical device regulations, Quality System Regulations (QSR/QMSR), and international regulatory requirements. Experience preparing and maintaining regulatory submissions, registrations, and technical documentation. Experience supporting product lifecycle management, engineering change assessments, and post-market regulatory activities. Experience reviewing product labeling, promotional materials, and technical documentation for regulatory compliance. Knowledge of
ISO 13485
quality management systems and applicable FDA regulations. Proficiency with Microsoft Office applications including Word, Excel, Outlook, and PowerPoint. Preferred Education/Experience Bachelor degree in biology, chemistry, or related technical discipline with experience supporting global regulatory submissions, registrations, and product approvals across multiple international markets. Knowledge of European Medical Device Regulation (EU MDR), FDA regulations, and other international regulatory frameworks. Familiarity with
ISO 10993
biocompatibility requirements and applicable international standards. Experience supporting combination products or pharmaceutical regulatory activities. Regulatory Affairs Certification (RAC) Experience participating in regulatory inspections, internal audits, and external agency audits. Knowledge of regulatory strategy development for new product introductions. Experience working within cross-functional product development and engineering teams. Strong understanding of global regulatory documentation, technical files, and design change management. Experience supporting medical device products throughout the full product lifecycle, from development through commercialization and post-market compliance.
