Regulatory Affairs Consultant

2 weeks ago

Somerville, United States Fladger Assoc. Inc. Full time
Job DescriptionJob DescriptionSomerville, NJContract Duration: 12 month unlimited extensionRate: Negotiable

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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