Regulatory affairs technician (PART TIME) - (C002)

Lhh; Castilla-La Mancha; A distancia; EUR 25.000 - 40.000; A tiempo parcial

Descripción de la vacante

A medical supplies company is seeking a Regulatory Affairs / Registers Technician to ensure compliance with Spanish and EU regulations for medical and surgical products. Applicants should have a university degree in a related field, along with proficiency in Spanish and English. The role initially allows for remote work, and candidates with at least 1 year of experience in regulatory compliance are preferred.

Formación

• At least 1 year of experience in regulatory compliance or quality management.
• Experience in medical devices or similar industries will be a significant advantage.

Responsabilidades

• Ensure compliance with Spanish and EU regulations for medical and surgical products.
• Maintain and oversee the quality management system.
• Act as the primary contact between the company and Spanish health authorities.

Conocimientos

Proficiency in Spanish and English

Attention to detail

Strong organizational and communication skills

Educación

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

Descripción del empleo

Overview

Our client, a known sanitary materials distributor that has started to develop its business in Spain with plans to grow and build a local team in the coming 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).
• 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, including academic credentials, documentation of experience, and any other required materials.
• Additional Information: We are open to freelancers.