Lead Specialist in Regulatory Affairs

1 week ago


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

Lead Specialist in Regulatory Affairs
Location: Remote
Contract Type: Long-term

We are seeking a highly skilled professional to join our team as a Lead Specialist in Regulatory Affairs. This role is crucial for ensuring compliance and facilitating the regulatory processes for our innovative medical devices.

Key Responsibilities:
  • Expertise in In Vitro Diagnostic (IVD) devices and their regulatory pathways.
  • Experience with US 510(k) submissions within the past five years.
  • Collaborate effectively with cross-functional teams to prepare and write regulatory submissions.
  • Demonstrate exceptional technical writing capabilities.
  • Exhibit strong communication skills to liaise with various stakeholders.
  • This position requires full onsite presence.
  • Providing examples of technical writing will be advantageous.
Educational Requirements:
  • A Bachelor's Degree in a scientific discipline (Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, Pharmacology, Mathematics, Engineering, or related fields) is preferred.
  • A Master's degree in a relevant technical area is advantageous.
  • Professional certification, such as RAC from the Regulatory Affairs Professionals Society, is a plus.
Experience Requirements:
  • A minimum of 5 years of experience in a regulated industry, particularly in medical devices or pharmaceuticals.


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