Regulatory Affairs Internship/Alternance
SonioPrenatal Screening company
ParisIntern
Bpifrance
Cross Border Impact Ventures
Elaia
OneRagtime
EIC Fund (European Innovation Council)
EASME - EU Executive Agency for SMEs
Legal & Compliance
About the role
TL;DR
Support regulatory compliance and documentation for medical devices.
- •Join our RAQA team and support our products' regulatory compliance.
- •Key Responsibilities Monitor and ensure the timely preparation and tracking of technical documentation related to design changes Assist in documentation preparation and publishing for regulatory submissions Assist in implementing an automated system for the regulatory and normative watch process Proactively monitor and ensure timely renewal of licenses 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 and provide support for regulatory impact analysis Provide support for Post-market compliance activities Requirements Ongoing Bac+5 in the medical devices field in preference Knowledge in medical devices, and software medical devices is a plus Knowledge in quality and regulatory affairs is a plus Fluent in French and English Team-oriented and values teamwork
Nice-to-have skills
Compliance Management
Domain expertise
healthcare
