Regulatory Affairs / Registers Technician - PART TIME -

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

Descripción de la vacante

A healthcare distributor is seeking a part-time Regulatory Affairs Technician in Madrid to ensure compliance with Spanish and EU regulations for medical products. Responsibilities include preparing documentation for AEMPS and maintaining quality management systems. Candidates should have a relevant degree, at least 1 year of experience, and be fluent in Spanish and English. The position offers remote work initially, with a salary of €27,500 for 20 hours per week.

Formación

• Minimum 1 year of experience in regulatory compliance or quality management.
• Experience in 13845 is required.

Responsabilidades

• 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.

Conocimientos

Regulatory compliance

Quality management

Attention to detail

Organizational skills

Fluent Spanish

Fluent English

Educación

Degree in Nutrition, Health Sciences, Biomedical Engineering

Descripción del empleo

PART TIME - Regulatory Affairs / Registers Technician

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)