Regulatory Intelligence Specialist

A company is looking for a Regulatory Intelligence Specialist to lead international product registrations and ensure regulatory compliance across worldwide markets.

Key Responsibilities

Lead international registrations by preparing and submitting documentation for product registrations in OUS markets

Engage with regulatory bodies and distributors to support registration and compliance efforts

Monitor global regulatory changes and propose solutions to mitigate risks

Required Qualifications

Bachelor's degree in a related field or equivalent experience

5+ years of medical device OUS registration experience

Experience with distributors and foreign regulatory authorities

RAC certification preferred; experience with FDA 510(k), EU MDR / CE Mark, or Health Canada is a plus

Strong knowledge of OUS medical device regulations and QMS standards