Regulatory Affairs Specialist

Regulatory Affairs Specialist

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.

Duties and Responsibilities

Global Product Registrations and Regulatory Approvals

• 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.

Regulatory Submissions and Product Lifecycle Support

• 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.

Regulatory Compliance and Post-Market Activities

• 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 regulatory compliance issues and supports resolution with Regulatory Affairs, Quality, and other appropriate functions.
• Monitors applicable regulatory requirements and regulatory developments and communicates relevant changes to internal stakeholders.

Regulatory Records and Documentation

• Maintains regulatory records, databases, logs, submissions, and other controlled information accurately and in accordance with company procedures and applicable regulatory requirements.
• Ensures 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.
• Maintains confidentiality and ensures regulatory information is handled in accordance with applicable company requirements.

General

• Adheres to all company policies, procedures, quality system requirements, and applicable business ethics standards.
• Participates in cross-functional projects and regulatory initiatives as assigned.
• Perform other duties and responsibilities as assigned.

Qualifications

Education and Experience

• 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.

Preferred Qualifications

• 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.

Skills & Abilities

• Proficient computer skills, including Microsoft Word, Excel, and PowerPoint. Experience with electronic document control systems, ERP systems, regulatory databases, and FDA eMDR reporting systems is preferred.
• 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.

Compensation

The anticipated range for this position is $80,000.00 to $95,000.00 at an annual base. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Working Conditions

• The Regulatory Affairs Specialist usually works in an office environment which includes laboratory and manufacturing areas. Occasional domestic travel may be required.
• The Regulatory Affairs Specialist works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.

Physical requirements

• Must be able to type using the keyboard of a computer.
• 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.