Senior Device Regulatory Lead for Global Submissions

elemed; Paris; Hybride; EUR 60 000 - 80 000; Temps partiel

Résumé du poste

A biopharma company in Paris is seeking a Senior Consultant for Device Regulatory Documentation & Compliance. In this role, you will mentor a team, develop regulatory documentation, and ensure compliance for medical devices and combination products. This opportunity is perfect for someone with 5–7 years of experience in the field, a thorough understanding of regulatory standards, and excellent communication skills. The position offers a supportive and collaborative environment in a fast-paced industry.

Qualifications

• 5–7 years of experience in medical devices and combination products, with a strong compliance/documentation track record.
• Deep understanding of ISO 13485, 21 CFR Part 820, 21 CFR Part 4, and EU MDR.
• Fluent English communication (written and spoken).

Responsabilités

• Lead and mentor the Regulatory Documentation & Compliance team.
• Develop and maintain essential regulatory documentation for submissions.
• Co-operate with various departments to build regulatory strategies.
• Monitor regulatory changes and advise the organization.
• Prepare Design Reviews, guiding teams with best practices.
• Support interactions with regulatory agencies for documentation.
• Define and implement systems for efficient regulatory integration.
• Key role in risk management and post-market surveillance documentation.

Connaissances

Regulatory strategy

Documentation systems

Mentoring

ISO 13485 compliance

Fluent English communication

Description du poste

A biopharma company in Paris is seeking a Senior Consultant for Device Regulatory Documentation & Compliance. In this role, you will mentor a team, develop regulatory documentation, and ensure compliance for medical devices and combination products. This opportunity is perfect for someone with 5–7 years of experience in the field, a thorough understanding of regulatory standards, and excellent communication skills. The position offers a supportive and collaborative environment in a fast-paced industry.