Regulatory Affairs Specialist II

Overview

This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail.

• Represent Regulatory Affairs (RA) on project teams by providing regulatory guidance throughout the product development cycle, coordinating team inputs for regulatory submissions, and reviewing and approving applicable design control documentation.
• Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications.
• Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc.
• Assess the 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/update technical files for CE marking with input from various functions (R&D, Quality, Medical, Manufacturing, etc.).
• Submit notifications to the EU Notified Body for significant changes to CE-marked products.
• Maintain regulatory documentation.
• Support special projects, as needed.

• 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.
• 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.
• Regulatory Affairs Certified RAC (RAPS).
• Proficient in using Microsoft Office.
• Strong communication and project management skills.
• Ability to handle multiple tasks and maintain attention to detail.
• Knowledge of 21 CFR 820 - Quality System Regulation, ISO 13485, and medical device standards and FDA guidance relevant to medical devices.

• Associate

• Contract

• Legal

• Pharmaceutical Manufacturing

Location:

Plano, TX

Salary range: $76,400.00-$