Clinical and Regulatory Affairs Officer CE M/F - NEWCLIP TECHNICS

Reporting to Céline, Regulatory Affairs Manager, you will actively contribute to the company's development within the regulatory team. In this capacity, you will compile the technical and clinical documentation of products in order to obtain and maintain the CE marking of the company's products. Your missions will be as follows:

1. Prepare CE marking technical and clinical documentation

• Draft associated technical documentation, instructions for use, and clinical files;
• Participate in responding to questions and non-conformities from the notified body during the review of CE marking files;
• Participate in project teams for the development of new products;
• Provide regular reporting to the Regulatory Affairs Manager on the progress of files.

1. Perform post-market follow-up

• Perform the collection and processing/analysis of post-market surveillance data.
• Draft post-market surveillance reports as part of maintaining CE marking and exports.

1. Perform related regulatory department activities

• Provide support to the export regulatory team during registrations and responses to questions;
• Participate in regulatory and standards monitoring and assess the nature of its impact/evolution on the company's activities / processes / products;
• Participate in drafting quality procedures related to regulatory activities;
• Assist R&D and Marketing departments on regulatory aspects;
• Validate marketing materials: brochures / surgical techniques, sales materials, commercial texts, training texts;
• Manage the archiving of CE marking files.

With a higher scientific education (Pharmacist, Master 2 in Regulatory Affairs, Engineer or equivalent), you have at least three years of experience in regulatory affairs, ideally in the medical device field. You have good knowledge of European and international regulations, and a specialization in health product regulation is an additional asset. Possessing an excellent analytical and synthesis spirit, you are recognized for your rigor, your organizational skills, and your ability to manage complex subjects. Your interpersonal skills allow you to interact effectively with various stakeholders in a collaborative and international environment. Finally, you master English at a professional level, allowing you to communicate easily both in writing and orally.

So, ready to join us? Join our innovative ETI showing 20% annual growth and evolve within an international company! Newclip is committed to promoting inclusion and diversity in its recruitment process. Thus, this position is open to all, without distinction.

Our recruitment process:

• Telephone exchange with the Recruitment team;
• First interview with one of the Recruitment Officers and your future manager;
• Second in-person interview to exchange with your N+2.