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Lead Specialist in Regulatory Affairs

2 months ago

Princeton, New Jersey, United States KYYBA Full time
Position Overview

This role is focused on enhancing regulatory compliance within the medical device sector. The successful candidate will collaborate with various departments to refine and advance regulatory processes.


Experience Requirements:
  • 3-5 years of experience in Medical Device Regulatory Affairs.
  • Proficient understanding of EU Medical Device Regulation (MDR).
  • Experience with Regulatory Change Assessment.
  • Knowledge of US and EU medical device submission processes.
  • Experience in supporting both internal and external audits.
  • Ability to work effectively in a cross-functional and matrixed environment.
  • Involvement in continuous improvement initiatives.

Educational Background:

A Bachelor’s Degree is required.


Key Responsibilities:

The individual in this position will:

  • Assist in the strategic implementation and operational management of regulatory affairs activities.
  • Oversee the development of product registration submissions, including progress reports, supplements, amendments, and periodic experience reports.
  • Revise and establish procedures to adapt to changes in the regulatory environment, particularly concerning EU MDR.
  • Identify opportunities for process improvements within regulatory affairs and drive these initiatives to completion.

Additional Qualifications:
  • Experience with IVD devices in Regulatory Affairs.
  • Recent experience with US 510(k) submissions within the last five years.
  • Proficient technical writing skills.
  • Strong communication abilities.
  • Examples of technical writing are preferred.