Regulatory Affairs Specialist (Autónomo)
Madrid
Contract
Negotiable
Regulatory
CR/583080_1773142752
Regulatory Affairs Specialist (Autónomo)
Regulatory Affairs Specialist (Autónomo) - Medical Devices
Location: Madrid, Spain (remote - 1 day per month travel)
Length: 9 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 9‑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, OneDrive).
- Solid knowledge of QMS and regulatory frameworks (MDR, CE, FDA, AEMPS).
- Must be able to work as an autónomo contractor in Spain.