Regulatory Affairs Specialist II

Responsibilities

This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, and for supporting international product registrations and related regulatory affairs activities.

• Prepare regulatory submissions for U.S. and European markets.
• Support international product registrations and execute procedures and systems to ensure product development meets regulatory requirements and business objectives.
• Represent Regulatory Affairs on project teams, providing regulatory guidance throughout the product development cycle, coordinating team inputs for submissions, and reviewing and approving design control documentation.
• Support international product registrations, including new registrations, re‑registrations, and product change registrations/notifications.
• Coordinate and collect registration information from R&D, Quality, Medical, Manufacturing, and other functions.
• Assess the necessity of 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 and update technical files for CE marking with input from various functions.
• Submit notifications to the EU Notified Body for significant changes to CE‑marked products.
• Maintain regulatory documentation.
• Support special projects as needed.

Requirements

• B.S. degree or higher in a life‑science or technical discipline (e.g., engineering, bioengineering, biology, chemistry).
• 2–5 years of medical‑device experience.
• Working knowledge of industry consensus standards and FDA guidance.
• At least 2 years of Regulatory Affairs experience in medical‑device regulations.
• Demonstrated success in taking products through FDA and EU Notified Bodies.
• Working knowledge of 510(k), MDD 93/42/EEC, MDR, 21 CFR 820 (Quality System Regulation), ISO 13485, and related medical‑device standards.
• Regulatory Affairs Certified (RAC) – RAPS preferred.
• Proficient in Microsoft Office.
• Strong communication and project‑management skills.
• Ability to handle multiple tasks with attention to detail.