Regulatory Affairs Consultant

Description:

Based in Belgium, this healthcare company has a wide range of products. They provide innovative solutions to their patients for pain relief and help play a key role in people's health and well-being.

🔹 The Opportunity

In this role as a Regulatory Affairs Consultant, you will work closely with the Director of Regulatory Affairs & Quality and review RA deliverables. You will be involved in the project plan and reviewing all technical file documentation as well as maintenance support work.

As a Regulatory Affairs Consultant you will:

• Maintain and manage regulatory affairs files, market authorizations, and CE-certifications.
• Develop and execute submission strategies for international product registrations.
• Ensure documentation compliance with EU MDR and other applicable regulations.
• Support audits and act as a liaison with regulatory authorities and CE-certification agencies.
• Assist in regulatory and quality-related activities, including Field Actions and CAPA resolutions.

🔹 Requirements:

• Medical Device experience
• Experience with MDR
• Fluent in English
• At least 5 years experience in Regulatory Affairs
• Hands on experience and autonomous in their approach

This role will be 80-100% weekly workload and can be done remotely!