Sr. Regulatory Affairs Specialist II

Senior Regulatory Affairs Specialist

Responsibilities

• Prepare regulatory submissions required to market medical devices in both the U.S. and Europe, including all related regulatory affairs activities.
• Provide regulatory guidance throughout the product development cycle and coordinate team inputs for regulatory submissions.
• Review and approve applicable design control documentation.
• Support international product registrations: new registrations, re‑registrations, and product change registrations/notifications.
• Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, and other functions.
• Assess necessity for submitting a 510(k) application for proposed device changes and prepare internal "Non‑Filing Justifications" for changes that do not require a 510(k) submission.
• Prepare/update technical files for CE marking with appropriate 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 engineering, bioengineering, biology, or 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.
• Regulatory Affairs Certified RAC (RAPS).
• Proficiency in Microsoft Office.
• Strong communication and project management skills.
• Ability to handle multiple tasks and attention to detail.
• Knowledge of 21 CFR 820, ISO 13485, and related medical device standards and FDA guidance.

• Mid‑Senior level

• Contract

• Legal
• Pharmaceutical Manufacturing