Regulatory Affairs Specialist

5 days ago


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

Fladger Assoc. Inc. is seeking a highly skilled Regulatory Affairs Consultant to join our team in Somerville, NJ.

About the Role

We are looking for an experienced professional with a strong background in regulatory affairs and medical devices. The successful candidate will be responsible for providing strategic guidance on regulatory matters, ensuring compliance with relevant regulations and guidelines.

Responsibilities
  • Regulatory Strategy Development: Collaborate with project teams to develop and implement effective regulatory strategies for medical device projects.
  • Document Review and Submission: Prepare and submit product, manufacturing, packaging, or labeling changes to European Notified Body and FDA, as scheduled.
  • Communication and Collaboration: Maintain daily communication with project teams and company Regulatory Management on project status and deliverables.
  • Experience and Skills: A minimum of 3-5 years of experience in regulatory affairs, preferably working on medical device projects. Strong knowledge of Class I, II, and III devices, complaint handling, international registration, and 510k submission.
What We Offer
  • Negotiable Salary: We offer a competitive salary based on experience and qualifications.
  • Benefits: Our benefits package includes [insert benefits here].
  • Growth Opportunities: As a key member of our team, you will have opportunities for professional growth and development.


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