Regulatory affairs technician (PART TIME)

Photocentric; Donostia/San Sebastián; A distancia; EUR 30.000 - 45.000; A tiempo parcial

Descripción de la vacante

A known sanitary materials distributor is seeking a part-time Regulatory Affairs / Registers Technician in Donostia/San Sebastián, Spain. The role involves ensuring compliance with Spanish and EU regulations, maintaining quality management systems, and liaising with health authorities. Candidates should have a relevant degree and at least one year of experience in regulatory compliance. Initial months will be remote, with the potential for a freelance arrangement.

Formación

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

Responsabilidades

• Ensure compliance with Spanish and EU regulations for medical products.
• Maintain the quality management system.
• Act as the contact between the company and Spanish health authorities.
• Work closely with business development and external regulatory consultants.

Conocimientos

Proficiency in Spanish

Proficiency in English

Attention to detail

Organizational skills

Communication skills

Educación

University degree in Nutrition, Health Sciences, or Biomedical Engineering

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).
• 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. This will include academic credentials, documentation of experience, and any other required materials.

Additional Information

We are open to freelanceers.

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