Regulatory Affairs Internship

Jobtailor; Paris; Sur place; EUR 18 000 - 24 000; Plein temps

Résumé du poste

Jobtailor is seeking a Regulatory Affairs intern in France to support documentation, regulatory submissions, and automated watch processes. You will coordinate with multiple internal teams to ensure timely regulatory activities and license renewals for the US market.

You will assist with marketing/clinical claims review and post-market compliance, gaining exposure to quality/regulatory affairs in medical devices.

Qualifications

• Knowledge of medical devices and related regulations.
• Familiar with regulatory submissions and post-market activities.
• Experience with regulatory quality processes is a plus.

Responsabilités

• Monitor and ensure timely preparation and tracking of technical documentation for design changes.
• Assist in documentation preparation and publishing for regulatory submissions.
• Assist in implementing an automated regulatory watch system.
• Monitor renewal of licenses for US market (SB Determination, Device Listing, Establishment License).
• Support centralized database for marketing and clinical claims review.
• Perform regulatory watch to ensure compliance with FDA, ISO, and other standards.
• Provide support for post-market compliance activities.

Connaissances

Medical devices knowledge

Software medical devices experience

Regulatory affairs experience

Formation

Bac+5 Master’s degree (Regulatory Affairs, or related field)

Description du poste

Responsibilities

• Monitor and ensure the timely preparation and tracking of technical documentation related to design changes, in coordination with the relevant teams.
• Assist in documentation preparation and publishing for regulatory submissions.
• Assist in implementing an automated system for the regulatory and standards watch process.
• Proactively monitor and ensure timely renewal of licenses, including Small Business Determination, Device Listing, and Establishment License for the US market.
• Facilitate promotional marketing review by setting up a centralized database of validated marketing and clinical claims.
• Perform regulatory watch to ensure compliance with FDA regulations, ISO standards, and other relevant regulatory requirements, and provide support for regulatory impact analyses.
• Provide support for post-market compliance activities.

Requirements

• Currently pursuing a Bac+5 (Master’s-level) degree in a medical devices-related field preferred (engineering degree, Master’s in Regulatory Affairs, etc.).
• Knowledge of medical devices; experience with software medical devices is a plus.
• Experience in quality and regulatory affairs is a plus.
• Fluent in French and English.
• Strong team player; this role will interact with most internal teams.