Regulatory Affairs Specialist

1 week ago


Somerville, New Jersey, United States Fladger Assoc. Inc. Full time
Job Description

We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Fladger Assoc. Inc.

Estimated Salary:$120,000 - $180,000 per year

Location:Somerville, NJ

Job Type:Contract, 12 month unlimited extension

About the Role

This is an excellent opportunity for a motivated individual with experience in regulatory affairs and medical devices.

The successful candidate will be responsible for representing Regulatory Affairs by attending project team meetings, providing regulatory strategies, reviewing project documentation, and participating in design control activities.

  • 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
Requirements
  • Bachelor's Degree in a related field
  • 3-5 years of experience as a Regulatory Affairs professional working on medical device projects
  • Experience with complaint handling, international registration, and 510k submission


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