NIHON KOHDEN OrangeMed

Compliance

• Coordinate and execute routine regulatory activities supporting the company’s worldwide medical device business
• Support product registrations, regulatory submissions, approvals, and post-market regulatory requirements across domestic and international markets
• Manage assigned regulatory activities, including collection, review, preparation, and maintenance of regulatory information and documentation
• Collaborate with internal departments, Nihon Kohden Sales Offices, distributors, and regulatory partners
• Coordinate country-specific product registrations, approvals, renewals, and shipping authorizations
• Maintain the Regulatory Approval Log and shared regulatory directory
• Coordinate requests for Certificates to Foreign Governments, Certificates of Free Sale, authentications, and other regulatory documentation
• Prepare and coordinate domestic and international product registration dossiers and regulatory submissions, including FDA 510(k) submissions
• Obtain technical, clinical, quality, labeling, and other supporting documentation for submissions
• Review regulatory documentation for completeness, consistency, and applicable requirements
• Maintain submission records and monitor submissions, amendments, notifications, and other regulatory activities through completion
• Coordinate responses to routine FDA and regulatory-authority questions, deficiencies, and requests for additional information
• Support regulatory assessments for new products, product changes, labeling changes, and activities affecting regulatory status or market authorization
• Coordinate and support Medical Device Reporting, vigilance, recall, and other regulatory reporting activities
• Perform initial assessments of regulatory reporting and notification requirements and escalate complex matters
• Support the Complaint Team with complaint entry, regulatory assessment, and reportability activities in the QMS
• Review IFUs, product labels, and promotional materials for regulatory alignment
• Identify and communicate potential regulatory compliance issues and support their resolution
• Monitor regulatory requirements and developments and communicate relevant changes to stakeholders
• Maintain regulatory records, databases, logs, submissions, and controlled information
• Support timely retrieval and presentation of documentation for stakeholders, authorities, audits, inspections, and authorized requests
• Adhere to company policies, procedures, quality system requirements, and business ethics standards
• Participate in cross-functional projects and regulatory initiatives
• Perform other assigned duties

Regulatory Affairs Specialist