Regulatory Affairs Technician

LHH; Murcia; A distancia; EUR 20.000 - 30.000; A tiempo parcial

Descripción de la vacante

A healthcare distributor is seeking a Regulatory Affairs / Registers Technician in Murcia, Spain. This part-time role involves ensuring compliance with medical regulations and maintaining quality management systems. The ideal candidate will have a relevant degree and at least one year of experience in regulatory compliance. Proficiency in Spanish and English is required. The role will initially be remote, supporting the company's growth in Spain.

Servicios

Remote work flexibility

Opportunity to work with international regulations

Formación

• At least 1 year of experience in regulatory compliance or quality management.
• Experience in medical devices or similar industries is a significant advantage.
• Demonstrate ability to manage remote responsibilities.

Responsabilidades

• Ensure compliance with Spanish and EU regulations for medical products.
• Maintain and oversee the quality management system.
• Act as the primary contact between the company and health authorities.
• Work closely with the Business Development team to meet obligations.

Conocimientos

Proficiency in Spanish

Proficiency in English

Knowledge of regulatory compliance

Experience in quality management

Educación

University degree in Nutrition, Health Sciences, Biomedical Engineering, or related fields

Descripción del empleo

Overview

Our client, a known sanitary materials distributor 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. (PART TIME JOB)

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).
• Additional Requirements: Teleworking/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.

Note: 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.