Regulatory Affairs Specialist

Job Summary Responsible for ensuring compliance of the company's orthopedic medical devices and manufacturing facility with applicable regulatory requirements. Manages product registrations, technical documentation, facility licenses, regulatory submissions, inspections, and communication with regulatory authorities to support business continuity and market access. Key Responsibilities Prepare and maintain product registrations and regulatory submissions.  Manage technical files, labeling, and regulatory documentation.  Ensure compliance with applicable medical device regulations and standards.  Obtain, maintain, and renew all facility licenses, permits, and certifications.  Assess regulatory impact of product, process, and facility changes.  Coordinate regulatory inspections, audits, and responses to findings.  Monitor regulatory updates and implement required changes.  Support new product development and market expansion activities.  Serve as the primary contact with regulatory authorities and certification bodies.