Regulatory Specialist, Engineer III

This is a fully remote position, open to applicants in Mexico.

📋 Description

• The Regulatory Specialist is primarily responsible for assisting the Regulatory Affairs (RA) team with the tasks outlined below.

• Provide ongoing regulatory assistance to the organization by reviewing and updating EU MDR/IVDR Technical Files and managing the RA mailbox in relation to Change Orders, product inquiries, complaints, and non-conformities.

• Facilitate product development through the implementation of globally-oriented regulatory strategies aimed at enhancing market access.

• Prepare regulatory plans and verification reports to ensure compliance with regulatory requirements across all target market regions.

• Responsible for the maintenance and updating of CE technical files for medical products.

• Engage in and ensure timely follow-up on customer inquiries received in the RA mailbox.

⛳️ Requirements

• A minimum of a BA/BS degree in a scientific or engineering discipline (preferred areas include biology, chemistry, material science, or polymer science).

• At least 2 years of experience in a regulated industry, specifically in pharmaceuticals or medical devices.

• Strong understanding of US and EU Medical Device and In Vitro Diagnostic regulations.

• Possess an analytical mindset with a strong capacity to learn new professional domains and business processes.

• Ability to work in a structured and goal-oriented manner.

• Exceptional communication and team-building capabilities.

🏝️ Benefits

• Health insurance

• Professional development opportunities