Regulatory Affairs Consultant
7 days ago
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.
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