Regulatory Affairs Consultant (Freelance)

Regulatory Affairs Consultant (Freelance) - Medical Devices

Location: Brussels, Belgium (hybrid)

Length: 12 months (possibility of extension)

Start Date: ASAP

We are partnered with a growing medical device manufacturer seeking an experienced Regulatory Affairs Consultant (Freelance) for a 12‑month engagement. This is an urgent requirement, and the company is ideally seeking someone who can start immediately.

Key Responsibilities

• Contribute to regulatory strategy for product development and design modifications.
• Develop and maintain technical documentation (e.g. Technical Files, STED, GSPR) for EU/UK compliance and US 510(k) submissions.
• Assist with the preparation and upkeep of Clinical Evaluation documentation.
• Compile and submit regulatory dossiers to Notified Bodies, including managing follow-up questions.
• Support Post-Market Surveillance (PMS) processes and activities.
• Review and approve product labelling, IFUs, and promotional content.
• Interpret applicable standards and regulatory requirements to maintain an effective QMS (ISO 13485).
• Participate in external audits (e.g. Notified Body and competent authority inspections).
• Provide regulatory input and occasional training to cross-functional teams.

Requirements

• Minimum 5 years' experience within Regulatory Affairs in the medical devices industry.
• Degree in a Life Sciences discipline or equivalent relevant experience preferred.
• Proficient in Microsoft Office tools (e.g. Word, Excel, cloud-based platforms).
• Strong understanding of global regulatory frameworks and QMS requirements (e.g. MDR, CE marking, FDA).