Responsibilities:

• Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area.
• Represent Regulatory Affairs by attending project team meetings, providing regulatory strategies, reviewing project documentation, and participating in design control activities, as scheduled.
• Prepare and submit product, manufacturing, packaging, or labeling changes to European Notified Body, based on project schedule
• Prepare 510(k)'s to FDA pertaining to device changes requiring FDA clearance, based on project schedule
• Submit notifications to company Regulatory Affiliates pertaining to changes to product, manufacturing, packaging, labeling, etc. and provide necessary documentation to country affiliates, based on project schedule.
• Daily communication and meeting attendance with project teams, as scheduled
• Daily or weekly communication with company Regulatory Management on project status and deliverables, as scheduled.

Experience:

• BS Degree
• 3-5 years as a Regulatory Affairs professional working on medical device projects
• Regulatory Affairs with Class I, II and III devices
• Experience with complaint handling, international registration and 510k submission
• Development of international and domestic regulatory submissions to the FDA and European Union Countries.