Regulatory Intelligence Specialist

Job Summary

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