Regulatory Affairs Specialist
Core
Maintain regulatory compliance and support submission activities for a global portfolio of orthopedic instruments.
Role type
Regulatory Affairs Specialist
Builds
Regulatory dossiers, pre-submission packages, and submission materials for global markets
Domain
Medical Devices / Orthopedics
Deliverable
client delivery
Required skills
Monitor global regulatory requirements, research approval pathways, compile compliance information, organize regulatory intelligence files, prepare regulatory dossiers, track submission status, coordinate regulatory agency meetings, review preclinical and clinical documentation
Preferred skills
Master's in Regulatory Science, experience in regulated industries, familiarity with medical device regulations
Technologies
Regulatory intelligence systems, submission management tools
Responsibilities
Monitor regulatory requirements and industry standards, research and compile compliance information, collect and maintain regulatory documentation, assist in preparing regulatory dossiers, track submissions and provide status updates, coordinate meetings with regulatory agencies, organize review of technical and clinical documentation
Seniority
Early-career to Mid-level, hands-on IC