Regulatory Affairs Consultant (Freelance)

Regulatory Affairs Consultant (Freelance)

Location: Brussels, Belgium (hybrid)

Length: 12 months (possibility of extension)

Start Date: June 2026

Key Responsibilities

• Support the development and maintenance of regulatory strategies for new and existing medical device products, including involvement with a Class IIb device.
• Contribute to regulatory project activities, working closely with regulatory colleagues and cross‑functional teams such as R&D and Clinical Affairs.
• Act as a technical regulatory subject matter expert, providing input and guidance to internal teams as required.
• Assist with regulatory inspections and external audits, including preparation of technical documentation for FDA and ISO assessors.
• Support interactions with Notified Bodies and contribute to global product registration and submission activities.
• Ensure assigned products and activities comply with applicable regulatory, quality, and internal standards.
• Operate in line with the Quality Management System and comply with site environmental, health, and safety requirements.
• Communicate effectively with Notified Bodies, Competent Authorities, and other regulatory agencies under supervision or guidance where appropriate.

Requirements

• Bachelor's degree (or equivalent) in a scientific discipline such as Chemistry, Biology, or Life Sciences.
• Prior Class IIb medical device experience is essential and ideally combination product experience.
• Regulatory affairs experience within the medical device or healthcare manufacturing sector.
• Strong knowledge of ISO 13485, EMC, MDD 93/42/EEC, MDR 2017/745 and FDA QSR.