Regulatory Affairs Specialist

1 week ago


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

Fladger Assoc. Inc. is seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team. This role is essential for ensuring compliance with regulatory standards in the medical device sector.

Key Responsibilities:
  • Actively participate in project team meetings, contributing regulatory insights and strategies.
  • Review and assess project documentation to ensure adherence to regulatory requirements.
  • Facilitate the preparation and submission of modifications related to product, manufacturing, packaging, or labeling to relevant regulatory bodies.
  • Prepare and submit 510(k) applications to the FDA for device modifications.
  • Coordinate with international regulatory affiliates to communicate product changes and provide necessary documentation.
  • Engage in regular communication with project teams and regulatory management to update on project status and deliverables.
Qualifications:
  • Bachelor's Degree in a relevant field.
  • A minimum of 3-5 years of experience in Regulatory Affairs, specifically within the medical device industry.
  • Proficient in handling regulatory matters for Class I, II, and III devices.
  • Experience in complaint management, international registration, and 510(k) submissions.
  • Demonstrated ability to develop regulatory submissions for both domestic and international markets.


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