Regulatory Affairs Specialist

Nihon Kohden Orange Med•Santa Ana, CA

2d•Hybrid

About The Position

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.

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.
Demonstrated 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.
Strong technical writing and verbal communication skills, with the ability to communicate effectively with internal departments, international sales offices, distributors, and regulatory partners.
Strong attention to detail and organizational skills, with the ability to coordinate multiple regulatory activities and priorities simultaneously.
Ability to independently manage routine regulatory activities, meet deadlines, and recognize when issues require escalation or additional regulatory expertise.
Ability to analyze information, identify potential regulatory issues, and exercise sound judgment within established procedures and regulatory requirements.
Ability to work effectively in a deadline-driven environment while maintaining accuracy and quality.
Fluent in English; proficiency in additional languages is a plus.

Nice To Haves

Completion of a relevant professional development program or certificate in Regulatory Affairs, such as UCI Regulatory Affairs and Compliance.
Regulatory Affairs Certification (RAC) is a plus.
Experience supporting FDA 510(k) submissions and/or international medical device registrations.
Experience with electronic regulatory submission, document management, or complaint/reportability systems.
Experience with electronic document control systems, ERP systems, regulatory databases, and FDA eMDR reporting systems is preferred.

Responsibilities

Coordinate with Nihon Kohden Sales Offices worldwide to obtain, maintain, and renew country-specific product registrations, approvals, and shipping authorizations.
Collect, review, verify, organize, and maintain regulatory information and documentation required to support product registrations and international market activities.
Maintain the Regulatory Approval Log and shared regulatory directory, ensuring regulatory information and documentation are current, accurate, accessible, and appropriately maintained.
Coordinate 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.
Track registration and renewal activities and communicate new, renewed, expired, or revised regulatory approvals and shipping authorizations to Quality Assurance and other appropriate functions.
Prepare, compile, format, and coordinate domestic and international product registration dossiers and regulatory submissions, including FDA 510(k) submissions and applicable international submissions.
Coordinate with internal departments to obtain technical, clinical, quality, labeling, and other supporting documentation necessary to ensure submissions are complete, accurate, and timely.
Review regulatory documentation for completeness, consistency, and alignment with applicable requirements prior to submission.
Maintain regulatory submission records and monitor submissions, amendments, notifications, and other regulatory activities through completion.
Coordinate responses to routine questions, deficiencies, and requests for additional information from the FDA and other regulatory authorities, working with appropriate internal subject matter experts.
Support regulatory assessments related to new products, product changes, labeling changes, and other activities that may affect regulatory status, approvals, registrations, or market authorization.
Coordinate and support Medical Device Reporting (MDR), vigilance, recall, and other applicable regulatory reporting activities, including collection and review of information required for regulatory assessments and submissions.
Perform initial assessments of regulatory reporting and notification requirements in accordance with applicable procedures and escalate complex or uncertain matters for further review.
Provide support to the Complaint Team with complaint entry, regulatory assessment, and reportability activities in our QMS, as directed.
Review labeling, including Instructions for Use (IFUs), product labels, and promotional materials, for alignment with applicable regulations, standards, guidelines, and approved or cleared product information.
Identify and communicate potential regulatory compliance issues and support resolution with Regulatory Affairs, Quality, and other appropriate functions.
Monitor applicable regulatory requirements and regulatory developments and communicate relevant changes to internal stakeholders.
Maintain regulatory records, databases, logs, submissions, and other controlled information accurately and in accordance with company procedures and applicable regulatory requirements.
Ensure regulatory information for assigned products and markets is current and supports timely retrieval and presentation of documentation for internal stakeholders, regulatory authorities, audits, inspections, and other authorized requests.
Maintain confidentiality and ensure regulatory information is handled in accordance with applicable company requirements.
Adhere to all company policies, procedures, quality system requirements, and applicable business ethics standards.
Participate in cross-functional projects and regulatory initiatives as assigned.
Perform other duties and responsibilities as assigned.