Regulatory Affairs Specialist II

Responsibilities

• Prepare regulatory submissions required to market medical devices in both the U.S. and Europe.
• Support international product registrations and related regulatory affairs activities.
• Execute procedures and systems to ensure product development meets regulatory requirements.
• Data analysis, problem solving, and attention to detail are required.
• Represent Regulatory Affairs on project teams, providing guidance throughout the product development cycle.
• Coordinate team inputs for regulatory submissions and review/approve design control documentation.
• Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications.
• Collect and coordinate specific registration information from R&D, Quality, Medical, Manufacturing, etc.
• Assess the need for submitting a 510(k) application for proposed device changes.
• Prepare internal "Non-Filing Justifications" 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, preferably in engineering, bioengineering, biology, or chemistry.
• 2-5 years Medical Device experience.
• Working knowledge of industry consensus standards and FDA guidance is required.
• At least 2 years 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, and other relevant regulations.
• Regulatory Affairs Certified RAC (RAPS).
• Proficient in using Microsoft Office.
• Strong communication and project management skills.
• Able to handle multiple tasks and maintain attention to detail.