Regulatory Affairs Associate

EKF Diagnostics; Boerne (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

EKF Diagnostics is seeking a Regulatory Affairs Associate based in Boerne, TX. This role will support regulatory compliance and product registrations for medical diagnostic products.

Responsibilities include preparing regulatory submissions, supporting product registrations, and collaborating with teams to ensure compliance with FDA and international regulations.

Qualifications

• Experience in regulatory affairs within a regulated industry is required.
• Strong organizational skills are essential.
• Solid understanding of regulatory documentation and compliance processes.

Responsibilities

• Prepare and maintain regulatory submissions.
• Support product registrations.
• Monitor regulatory requirements and ensure compliance.

Skills

Regulatory compliance

Organizational skills

Understanding of regulatory documentation

Job description

Regulatory Affairs Associate

EKF is seeking a Regulatory Affairs Associate, based in Boerne, TX, to support regulatory compliance and product registrations for medical diagnostic products.

Responsibilities include preparing and maintaining regulatory submissions, supporting product registrations, monitoring regulatory requirements, and collaborating with cross-functional teams to ensure compliance with FDA and international regulations.

Candidates should have experience in regulatory affairs within a regulated industry, strong organizational skills, and a solid understanding of regulatory documentation and compliance processes.