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).
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