Regulatory Affairs (Part Time)

LHH; Barcelona; A distancia; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A known sanitary materials distributor is looking for a Regulatory Affairs / Registers Technician in Barcelona, Spain. The candidate will ensure compliance with Spanish and EU regulations, maintain quality management systems, and act as the primary contact with health authorities. A university degree and at least 1 year of regulatory experience are required. Remote work is available initially.

Servicios

Freelance opportunities

Formación

• A university degree in a relevant field is preferred.
• At least 1 year of experience in regulatory compliance or quality management is required.

Responsabilidades

• Ensure compliance with Spanish and EU regulations for medical products.
• Maintain and oversee the quality management system.
• Act as the primary contact with Spanish health authorities.
• Collaborate with Business Development and external consultants.

Conocimientos

Proficiency in Spanish

Proficiency in English

Attention to detail

Strong organizational skills

Communication skills

Educación

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

Descripción del empleo

Our client, a known sanitary materials distributor that has recently started developing their business in Spain with plans to grow and build a local team in the coming months, is looking for a Regulatory Affairs / Registers Technician.

Responsibilities :

1. Regulatory Compliance : Ensure compliance with Spanish and EU regulations for medical and surgical products, including preparing documentation for the Spanish Agency of Medicines and Health Products (AEMPS).
2. Quality Management : Maintain and oversee the quality management system to ensure adherence to high standards.
3. Documentation and Liaison : Act as the primary contact between the company and Spanish health authorities, especially during the initial project phase.
4. Collaboration : Work closely with the company’s Business Development and Managing Director, as well as external regulatory consultants, to meet all legal and regulatory obligations.

Qualifications :

• Educational Background : A university degree in Nutrition, Health Sciences, Biomedical Engineering, or related fields is preferred. Relevant experience will also 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 is a plus.

Skills :

• Proficiency in Spanish and English (Catalan is a plus).
• Excellent attention to detail, strong organizational and communication skills, and a responsible attitude.

Additional Requirements :

• Telecommuting : For the initial months, the role will be remote. Applicants must demonstrate that this arrangement will not affect their ability to perform the responsibilities of a responsible technical person.
• Regulatory Submission :
• Once selected, the candidate's application will be submitted to AEMPS for verification, including academic credentials, experience documentation, and other required materials.

Additional Information :

We are open to freelance candidates.