Regulatory Affairs / Registers Technician - PART TIME -

LHH; Vigo; A distancia; EUR 28.000; A tiempo parcial

Descripción de la vacante

A growing medical products distributor is seeking a Part-Time Regulatory Affairs / Registers Technician in Vigo, Spain. Responsibilities include ensuring compliance with Spanish and EU regulations, preparing documentation for AEMPS, and maintaining the quality management system. Candidates should have a degree in a related field, at least 1 year of experience in regulatory compliance, and be fluent in Spanish and English. This role offers remote work during initial months.

Formación

• Minimum 1 year of experience in regulatory compliance or quality management.
• Experience in 13845 required.
• Strong attention to detail, organizational skills, and accountability.

Responsabilidades

• Ensure compliance with Spanish and EU regulations for medical products.
• Prepare documentation for the Spanish Agency of Medicines and Health Products (AEMPS).
• Maintain the quality management system.
• Liaise with Spanish health authorities during the initial phase.
• Collaborate with internal leadership and external consultants to meet regulatory requirements.

Conocimientos

Regulatory compliance

Quality management

Fluent in Spanish

Fluent in English

Attention to detail

Organizational skills

Educación

Degree in Nutrition, Health Sciences, Biomedical Engineering, or related field

Descripción del empleo

PART TIME - Regulatory Affairs / Registers Technician

About the Company:

Our client is a distributor of sanitary materials, newly expanding into Spain with plans to build a local team.

Key Responsibilities

• Ensure compliance with Spanish and EU regulations for medical and surgical products.
• Prepare documentation for the Spanish Agency of Medicines and Health Products (AEMPS).
• Maintain the quality management system.
• Liaise with Spanish health authorities during the initial phase.
• Collaborate with internal leadership and external consultants to meet regulatory requirements.

Requirements

• Degree in Nutrition, Health Sciences, Biomedical Engineering, or related field (preferred).
• Minimum 1 year of experience in regulatory compliance or quality management.
• Experience in 13845. (required)
• Fluent in Spanish and English; Catalan is a plus.
• Strong attention to detail, organizational skills, and accountability.

Additional Info

• Remote work during initial months; candidates must ensure full responsibility can be maintained.
• Selected candidate’s credentials will be submitted to AEMPS for verification.
• Salary 27.500€ part time (20h per week)