Regulatory Affairs (Part Time)

Descripción del empleo

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.

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.

Información extra

Status

Inactiva

Estudios requeridos

E.S.O

Localización

Barcelona

Tipo de contrato

Trabajo estudiantes

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Español