Senior Regulatory Affairs Technician

JOB SUMMARY:

The purpose of this role is to ensure that all products manufactured, imported, or marketed by the company comply with applicable national and European regulations, particularly in the areas of medical devices and cosmetics. The Regulatory Affairs Technician is responsible for obtaining and maintaining regulatory authorizations, preparing and updating technical documentation, assessing regulatory compliance of suppliers, and supporting audits and cross-functional teams. This role is key to maintaining regulatory compliance throughout the product lifecycle and ensuring alignment with authorities such as AEMPS and with standards like ISO 13485.

Key Responsibilities 1. Regulatory Authorizations• Obtain and maintain licenses for manufacturing and importing medical devices.• Handle import authorizations for cosmetic products.• Submit applications and/or register products with national and European authorities. 2. Regulatory Documentation• Prepare and update technical files, risk analyses, declarations of conformity, and post-market surveillance reports for medical devices.• Prepare safety evaluation reports and technical documentation for cosmetics.• Draft REACH compliance reports for relevant product categories. 3. Supplier Regulatory Evaluation• Request regulatory documentation from subcontracted suppliers.• Draft and maintain Technical Quality Agreements.• Coordinate authorization procedures with authorities for subcontracted activities. 4. Regulatory Support and Coordination• Provide regulatory documentation to customs agents and resolve related issues.• Validate regulatory documentation for marketed or proposed products.• Prepare declarations, technical files, and justifications related to specific product categories (e.g., dermobands).• Support implementation of product labelling and marketing claims.• Request national product codes (CN codes) from the General Council of Pharmacists.• Prepare documentation required by clients for registration with national health authorities. 5. Certification and Audit Compliance• Ensure compliance with regulatory standards required by certification bodies (e.g., AENOR).• Maintain documentation and processes in accordance with ISO 13485 requirements for medical devices.