Regulatory Affairs Specialist

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 elevate 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 Requirements Bachelor’s degree in Regulatory Affairs, Engineering, Biological Sciences, Life Sciences, or a related technical field preferred Minimum 3 years of relevant professional experience in Regulatory Affairs, preferably within the medical device industry Working knowledge of U.S. FDA and applicable international medical device regulatory requirements, including familiarity with EU Medical Device Regulation (MDR) Working knowledge of medical device product registration, approval, and regulatory submission processes Working knowledge of medical device quality system requirements, including ISO 13485 and FDA 21 CFR Part 820 Understanding of medical device product development and product lifecycle processes and their regulatory impact Experience collecting, reviewing, organizing, and maintaining technical and regulatory information from multiple sources with a high degree of accuracy Proficient computer skills, including Microsoft Word, Excel, and PowerPoint Experience with electronic document control systems, ERP systems, regulatory databases, and FDA eMDR reporting systems preferred Strong technical writing and verbal communication skills Strong attention to detail and organizational skills Ability to independently manage routine regulatory activities, meet deadlines, and recognize when issues require escalation Ability to analyze information, identify potential regulatory issues, and exercise sound judgment Ability to work effectively in a deadline-driven environment while maintaining accuracy and quality Fluent in English; proficiency in additional languages is a plus Ability to type using a computer keyboard Ability to communicate clearly and effectively in person, by telephone, and through written communication Must be able to lift and carry up to 30 lbs Core Competencies Demonstrates expertise in regulatory affairs for medical devices, including product registration, submission processes, and compliance with FDA and international regulations. Proficient in technical writing, documentation management, and cross-functional collaboration to ensure regulatory alignment and support product lifecycle activities. Highest-signal resume keywords Regulatory Affairs Experience FDA 510(k) Submissions Medical Device Quality System Requirements Technical Writing Skills Regulatory Compliance Monitoring ATS Optimization Keywords Hard Skills Regulatory Submissions Product Registration Regulatory Documentation Management Regulatory Assessment Medical Device Reporting ISO 13485 Knowledge FDA 21 CFR Part 820 Knowledge Regulatory Information Collection Technical Documentation Review Regulatory Submission Monitoring Soft Skills Attention to Detail Organizational Skills Analytical Skills Communication Skills Problem-Solving Skills Industry Keywords Medical Device Industry U.S. FDA Regulations EU Medical Device Regulation (MDR) Regulatory Compliance Product Lifecycle Processes Tools & Technologies Microsoft Word Microsoft Excel Microsoft PowerPoint Electronic Document Control Systems Regulatory Databases FDA eMDR Reporting Systems #J-18808-Ljbffr