Staff Regulatory Affairs Specialist

Job Description

This position is responsible for preparing and executing regulatory submissions required to obtain and maintain market authorization for new and modified medical devices in the United States, Europe, and other international markets. The role leads and supports a broad range of regulatory affairs activities, including the development, implementation, and management of regulatory processes, procedures, and systems that ensure compliance with applicable global regulations throughout the product lifecycle. The position partners closely with cross-functional teams to ensure that product development activities and design changes comply with applicable regulatory requirements while supporting business objectives and product commercialization strategies.

Key responsibilities include ensuring regulatory requirements are appropriately addressed across verification and validation, risk management and usability, reprocessing and biocompatibility, and software development activities. The role requires independent analysis and resolution of complex regulatory issues, evaluation of technical and clinical data, application of risk-based decision-making, and development of regulatory strategies that support product development, lifecycle management, and organizational goals.

Responsibilities

• Coordinate, prepare, and follow up with FDA Premarket Notification 510(k) submissions in a timely manner.
• Act as liaison with FDA regarding product clearance.
• Assess necessity for submitting a 510(k) application for proposed device changes.
• Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission.
• Prepare technical files / dossiers for International Registrations with appropriate input from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
• Review and approve labeling, promotional and advertising materials to ensure regulatory compliance.
• Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
• Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
• Support International Registrations as it relates to product changes and/or new product launches.
• Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
• Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.
• May provide leadership by assigning work and resolving complex problems.

Minimum Requirement

• Bachelor's degree in Regulatory Science, Biomedical, Pharmaceutical, or related scientific field (or equivalent)
• Minimum of 5 years of Regulatory Affairs experience in the medical device industry, preferably with FDA Class II and/or Class III devices

Required Experience

• Medical device regulatory submission experience for the U.S., Europe, and/or international markets.
• Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions (PMA, 510(k), IDE) to FDA and other regulatory agencies
• Experience supporting product development, design changes, and product lifecycle management.
• Ability to evaluate technical/clinical data and independently resolve complex regulatory issues.
• Knowledge of regulatory requirements across V&V, risk management, usability, reprocessing, biocompatibility, and software development.
• Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
• Strong cross-functional communication and risk-based regulatory strategy development.