Regulatory Affairs Officer in the Healthcare Industry (M/F)

Job Description:

Our client is a recognized player operating in the in vitro diagnostics and clinical research environment. As part of its business development, it is looking for a DMDIV Regulatory Affairs Manager (M/F) to support its compliance, structuring, and development challenges.

Missions

Reporting to management, you will work on a scope combining DMDIV regulatory affairs and clinical study compliance.

On the DMDIV activity***Write, prepare, adapt, and review protocols related to the DMDIV performance plan: scientific validity, analytical performance, clinical performance, and post-market surveillance

• Participate in the creation and updating of technical documentation in connection with various stakeholders
• Ensure the compliance of activities with respect to the requirements of the applicable European regulation and, depending on projects, FDA provisions
• Analyze regulatory developments and ensure their internal dissemination
• Support and train operational teams on the regulatory requirements applicable to DMDIV

On the clinical studies activity***Guarantee the regulatory, ethical, and GDPR compliance of clinical studies before, during, and after their closure

• Participate in the writing, preparation, adaptation, and review of submission documents for initial filings and clinical study amendments
• Ensure the follow-up of files with competent authorities and relevant bodies
• Work on studies of type RIPH 1, 2, 3, NRIPH, as well as on pre-market, post-market, and patient pre-screening projects
• Train clinical operations teams on new procedures, tools, and regulations
• Participate in the deployment and proper use of study management tools such as eTMF / eISF
• Act as a liaison with external legal contacts when necessary

Transversal missions***Ensure active regulatory monitoring within your scope

• Advise internal teams on regulatory topics related to ongoing projects
• Contribute to business development by providing regulatory expertise on certain specific requests or offers
• Write, update, and apply procedures related to your activity

Profile Description:

What we are looking for in our future collaborator: You hold a master's degree in medical sciences or an equivalent field. You must have a minimum of 8 years of experience in clinical trial regulatory affairs. You possess solid knowledge of drug clinical trial regulations and international standards (GCP/ ICH). You possess excellent writing skills allowing you to adapt your communication according to the interlocutors. You are recognized for your organizational skills, team spirit, dynamism, and rigor.