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. Coordinate Post‐Market Surveillance activities.
Review/approve labelling, artwork, and marketing materials. Interpret standards and regulatory requirements for QMS implementation (ISO 13485). Support external audits (including AEMPS and Notified Body). Provide RA guidance and training to team members. Requirements 5+ years' experience in Medical Device Regulatory Affairs. Degree in Life Sciences or equivalent experience (desirable). Strong Microsoft Office skills (Word, Excel, One Drive). Solid knowledge of QMS and regulatory frameworks (MDR, CE, FDA, AEMPS). Must be able to work as an autónomo contractor in Spain.