Regulatory Affairs Specialist (Autónomo)

Regulatory Affairs Specialist (Autónomo) - Medical Devices

Location: Barcelona, Spain (remote - 2 days per month travel)

Length: 12 months (possibility of extension)

Start Date: ASAP

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

Key Responsibilities

• Support regulatory strategy for new products and design changes.
• Create and maintain Technical Files, STED, and GSPR checklists for EU/UK/AEMPS markets and 510(k) submissions.
• Support Clinical Evaluation Reports (CERs).
• Prepare submissions for the Notified Body and respond to regulatory queries.