Regulatory Affairs Specialist

NIHON KOHDEN OrangeMed

Regulatory Affairs Specialist supporting Nihon Kohden Orange Med’s worldwide medical device registrations, submissions, and post-market compliance. Coordinating FDA 510(k), international approvals, and regulatory documentation.

Posted 8/22/2026full-timeSanta Ana • California • 🇺🇸 United StatesMid-LevelSenior💰 $80,000 - $95,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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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 ExperienceFDA 510(k) SubmissionsMedical Device Quality System RequirementsTechnical Writing SkillsRegulatory Compliance Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsProduct RegistrationRegulatory Documentation ManagementRegulatory AssessmentMedical Device ReportingISO 13485 KnowledgeFDA 21 CFR Part 820 KnowledgeRegulatory Information CollectionTechnical Documentation ReviewRegulatory Submission Monitoring

Soft Skills

Attention to DetailOrganizational SkillsAnalytical SkillsCommunication SkillsProblem-Solving Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointElectronic Document Control SystemsRegulatory DatabasesFDA eMDR Reporting Systems

Industry Keywords

Medical Device IndustryU.S. FDA RegulationsEU Medical Device Regulation (MDR)Regulatory ComplianceProduct Lifecycle Processes

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Occasional domestic travel may be required
Standard work week, with some evenings and weekends as needed