Regulatory Affairs Specialist

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The Regulatory Affairs Specialist is responsible for coordinating and executing routine regulatory activities that support the company’s worldwide medical device business. This position supports product registrations, regulatory submissions, approvals, and post-market regulatory requirements across domestic and international markets.

The Regulatory Affairs Specialist independently manages assigned regulatory activities, including the collection, review, preparation, and maintenance of regulatory information and documentation. The position collaborates with internal departments, Nihon Kohden Sales Offices, distributors, and regulatory partners to ensure regulatory requirements are appropriately addressed and maintained throughout the product lifecycle. The position exercises sound judgment in managing routine regulatory matters and escalates complex or higher-risk issues as appropriate.

• Coordinates with Nihon Kohden Sales Offices worldwide to obtain, maintain, and renew country-specific product registrations, approvals, and shipping authorizations.
• Collects, reviews, verifies, organizes, and maintains regulatory information and documentation required to support product registrations and international market activities.
• Maintains the Regulatory Approval Log and shared regulatory directory, ensuring regulatory information and documentation are current, accurate, accessible, and appropriately maintained.
• Coordinates regulatory requests from Sales Offices and internal stakeholders, including Certificates to Foreign Governments (CFGs), Certificates of Free Sale, authentications, and other regulatory certificates or documentation.
• Tracks registration and renewal activities and communicates new, renewed, expired, or revised regulatory approvals and shipping authorizations to Quality Assurance and other appropriate functions.

• Prepares, compiles, formats, and coordinates domestic and international product registration dossiers and regulatory submissions, including FDA 510(k) submissions and applicable international submissions.
• Coordinates with internal departments to obtain technical, clinical, quality, labeling, and other supporting documentation necessary to ensure submissions are complete, accurate, and timely.
• Reviews regulatory documentation for completeness, consistency, and alignment with applicable requirements prior to submission.
• Maintains regulatory submission records and monitors submissions, amendments, notifications, and other regulatory activities through completion.
• Coordinates responses to routine questions, deficiencies, and requests for additional information from the FDA and other regulatory authorities, working with appropriate internal subject matter experts.
• Supports regulatory assessments related to new products, product changes, labeling changes, and other activities that may affect regulatory status, approvals, registrations, or market authorization.

• Coordinates and supports Medical Device Reporting (MDR), vigilance, recall, and other applicable regulatory reporting activities, including collection and review of information required for regulatory assessments and submissions.
• Performs initial assessments of regulatory reporting and notification requirements in accordance with applicable procedures and escalates complex or uncertain matters for further review.
• Provides support to the Complaint Team with complaint entry, regulatory assessment, and reportability activities in our QMS, as directed.
• Reviews labeling, including Instructions for Use (IFUs), product labels, and promotional materials, for alignment with applicable regulations, standards, guidelines, and approved or cleared product information.
• Identifies and communicates potential…