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POSTULER

Emplacement

Paris
75001
Île-de-France
France

Contrat

À plein temps, Durée indéterminée

Date de publication:

2025-06-03

Online to:

2025-08-02
EUR 15.00 HOUR

Device Regulatory Documentation & Compliance Senior Manager

If you're ready to push the boundaries of global health and make a lasting impact, this role at a well-established Medical Technology company could be your next best move. Proclinical is seeking a dedicated professional to join our client's team as a Device Regulatory Documentation & Compliance Senior Manager. In this role, you will lead the preparation and management of essential documentation for the registration of medical devices and combination products, focusing on compliance with US and EU regulations. This position involves developing regulatory strategies, overseeing documentation processes, and collaborating with cross-functional teams to ensure regulatory compliance. Lead and manage the team responsible for producing and maintaining regulatory documentation. Ensure all documents for medical device registration are accurate and compliant with relevant regulations. Support internal audits and provide training on best practices in regulatory documentation. Provide necessary documentation for regulatory dossiers. Lead cross-functional teams to align documentation with design inputs and international requirements. Establish a comprehensive documentation system for accessibility and traceability. Coordinate the preparation of documentation for regulatory filings and respond to inquiries from authorities. Offer regulatory guidance throughout the product lifecycle, including risk management and post-market surveillance. Identify and implement improvements to streamline documentation practices. Expertise in managing documentation and compliance for medical devices and combination products. Fluent in English, both oral and written. By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -

POSTULER

Device Regulatory Documentation & Compliance Senior Ma…

Emplacement

Contrat

Date de publication:

Online to:

Device Regulatory Documentation & Compliance Senior Manager

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