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Quality Assurance & Regulatory Affairs Specialist

Hybrid in Terrassa·Full-time·Added 5 days ago (last checked 22 Oct)

Agency

Empatif Recruiting

47 open roles

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Our summary

Hours: Jornada intensiva on Fridays
Work mode: Hybrid, Terrassa
Contract: Full-time
English: Required
Experience: 2+ years
Education: University degree

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Skills

This job advert was originally written in Spanish.

Requirements

What we're looking for

University degree in a scientific or technical discipline: Biology, Chemistry, Biomedical Engineering, Industrial Engineering, or similar degrees.
Minimum of 2 years of professional experience in quality departments or quality management systems, preferably in industrial environments or regulated sectors.
Practical experience and knowledge of the ISO 9001 standard (essential).
Knowledge of quality management systems (QMS), document management, procedures, and audit processes.
High level of English, both written and spoken, especially for the comprehension, preparation, and management of technical and regulatory documentation.
Organized, methodical, and analytical profile, with attention to detail, initiative, capacity for learning, and good communication skills.

Nice to have

Knowledge of the ISO 13485 standard.
Experience in sectors such as Medical Devices, pharmaceutical, biotechnology, or the technology industry.
Previous experience in Regulatory Affairs, compliance, certifications, or regulatory documentation.
Complementary training or a master's degree in Quality Management, Regulatory Affairs, or related fields.
Experience in the preparation and participation in internal or external audits.

Pay & benefits

What you'll get

Direct incorporation into a consolidated technology company, with an international presence and activity in the industrial and medical sectors.
Participation in transversal projects and collaboration with different areas and business units of the company.
Flexible schedule: entry between 8:00 and 9:30 h, Monday to Thursday, with intensive working days on Fridays.
Possibility of teleworking once the initial training period has been completed: 1 day per week or 2 afternoons.
Salary to be assessed based on experience, knowledge, and suitability for the position.
Professional, technological, and international environment, with opportunities for continuous learning and development.

The role

We are looking to hire a Quality Assurance & Regulatory Affairs Specialist to support the corporate head of Quality and Regulatory Affairs, participating in the management of quality systems, regulatory compliance, and regulatory documentation for the various business units.

What you'll do

Preparation, review, update, and maintenance of Quality Management System (QMS) documentation: procedures, work instructions, records, and technical documentation.
Support in the maintenance and continuous improvement of the quality system, especially under ISO 9001 and ISO 13485 standards.
Management and monitoring of documentation related to regulatory affairs, regulatory compliance, and legal requirements applicable to the company's activity.
Preparation, review, and maintenance of regulatory documentation, certifications, declarations of conformity, and other associated records.
Monitoring of regulatory changes and analysis of requirements applicable to different products and business units.
Participation in the preparation, coordination, and monitoring of internal and external audits, with the objective of progressively assuming greater responsibility in their management.
Collaboration with different departments to ensure compliance with quality procedures and requirements.
Support in the management of non-conformities, corrective and preventive actions (CAPA), and continuous improvement initiatives.
Participation in corporate projects related to new standards, regulations, and quality systems, contributing to their coordination and monitoring.

About Empatif Recruiting

Empatif Recruiting is a specialized technical and industrial recruitment agency based in Vic, Spain. The company focuses on connecting skilled professionals with opportunities in sectors such as engineering, construction, industrial maintenance, and technical services, operating primarily within the Catalan and Spanish markets. Their recruitment services cover a wide range of roles, from technical architects and structural engineers to commercial and administrative positions, with a strong emphasis on bilingual (Catalan/Spanish and English) capabilities for international-facing roles.

For international professionals, Empatif Recruiting offers a direct gateway into Spain's industrial and technical job market, particularly in Catalonia. The company's roles frequently require technical certifications (PRL, quality control, electromechanical maintenance) and often list English as a requirement, making it accessible for non-Spanish speakers. Their presence in Vic, a city in the Barcelona province, places them within a dynamic regional economy while maintaining a local, specialized recruitment approach.

Industry: Recruiting
Website: empatif.com

In their own words

About the company & team

Empatif is a group specialized in Human Resources management with more than 25 years of experience in the market. We are strategically located in different points across the national geography.

Our main mission is to make people happy, help them grow, and ensure they become more competitive. We believe in the development of people.

We enhance the value of companies through people. Really.

From our Recruiting division, we collaborate with an international technology company located in Terrassa, specialized in the development of high-precision solutions in the field of optical metrology, with applications in both the industrial and medical sectors.

All open roles at Empatif Recruiting