Regulatory Affairs Specialist II – Medical Devices

Cordis, LLC; Nuevo León; On-site; MXN 1,300,000 - 1,857,000; Full time

Job summary

Cordis in Mexico is seeking a Regulatory Affairs Specialist II to support regulatory submissions, registrations and lifecycle activities for our cardiovascular devices. You will work closely with Manufacturing, Quality, Engineering and Product Development at the Juarez site to ensure global regulatory compliance.

The role requires 3+ years in regulatory affairs, a Bachelor's degree, and knowledge of FDA, EU MDR, ISO 13485 and MDSAP.

Qualifications

• Minimum 3+ years of regulatory affairs experience with a Bachelor's degree.
• Experience with FDA regulations, EU MDR, ISO 13485, MDSAP and design controls.
• Able to work in a cross-functional manufacturing environment and communicate effectively.

Responsibilities

• Support regulatory submissions, product registrations, and change assessments.
• Collaborate with Manufacturing, Quality, Engineering, Operations, and Product Development teams.
• Provide regulatory support for investigations, CAPAs, complaints, audits, and inspections.
• Interface with regional regulatory teams to support product registrations, approvals, and ongoing market compliance.
• Contribute to continuous improvement of regulatory policies, procedures, and quality system processes.
• Ensure compliance with FDA, EU MDR, ISO 13485, MDSAP, CE Marking and other applicable regulatory requirements.
• Perform other duties as assigned.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory submissions

Quality systems

Documentation

Education

Bachelor's degree in a relevant field

Advanced degree

Tools

Regulatory databases

Job description

Cordis in Mexico is seeking a Regulatory Affairs Specialist II to support regulatory submissions, registrations and lifecycle activities for our cardiovascular devices. You will work closely with Manufacturing, Quality, Engineering and Product Development at the Juarez site to ensure global regulatory compliance.

The role requires 3+ years in regulatory affairs, a Bachelor's degree, and knowledge of FDA, EU MDR, ISO 13485 and MDSAP.