Regulatory Affairs Specialist (Autónomo)
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, OneDrive).
- Solid knowledge of QMS and regulatory frameworks (MDR, CE, FDA, AEMPS).
- Must be able to work as an autónomo contractor in Spain.
FAQs
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