Regulatory Technician part time

Our client, a known sanitary materials distributor (regulation 13485) that just started to develop their business in Spain with a perspective of growing and build a team locally in the following months, is looking for a Regulatory Affairs / Registers Technician. Position based in Barcelona with felxible schedule. Responsibilities: · Regulatory Compliance: Ensure compliance with Spanish and EU regulations for medical and surgical products, including preparing documentation to the Spanish Agency of Medicines and Health Products (AEMPS). · Quality Management: Maintain and oversee the quality management system to ensure adherence to the highest standards. · Documentation and Liaison: Act as the primary contact between the company and Spanish health authorities, particularly during the initial project phase. · Collaboration: Work closely with the company’s Business Development and Managing Chief and external regulatory consultants to ensure all legal and regulatory obligations are met. Qualifications: ·Educational Background: A university degree in Nutrition, Health Sciences, Biomedical Engineering, or related fields is preferred. However, experience in similar roles will be highly valued. ·Experience: At least 1 year of experience in regulatory compliance or quality management is required. Experience in medical devices or similar industries will be a significant advantage. Skills: · Proficiency in Spanish and English (Catalan is a plus). · Excellent attention to detail, strong organizational and communication skills, and the ability to bear responsibility. Additional Requirements: ·Telematic Work: For the initial months, the role will be remote. Applicants must demonstrate that this arrangement will not affect their ability to fulfil the responsibilities of a responsible technical person. ·Regulatory Submission: ·After the candidate is chosen, their application will be forwarded to AEMPS for verification. This will include academic credentials, documentation of experience, and any other required materials. Additional Information: We are open to freelanceers.

Location: Catalonia, ES

Posted Date: 8/13/2025