10 publicaciones de empleo destacadas de biomedical engineering en poligono industrial alcobendas, md (¡Están contratando!)

Regulatory Affairs & Quality Assurance Manager (RA/QA Manager)
Medilnt —Poligono Industrial Alcobendas, Madrid provincia
- Desde 800 € al mes
- Media jornada
- Español
- Inglés
Solicitud rápida
Artificial Intelligence Research Scientist
SpotLab —Madrid, Madrid provincia
- Jornada completa
- Español
- Doctorado
- Informática
Solicitud rápida
Internship: Demand Planner Intern
Philips —Madrid, Madrid provincia
- Media jornada
- Español
- Microsoft Excel
- Inglés
Product Data Officer - Medical Devicer (Fixed-Term Contract)
IQVIA —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Inglés
- Grado
5d
Artificial Intelligence Research Internship
SpotLab —Madrid, Madrid provincia
- Español
- Informática
- Inglés
Solicitud rápida
Field Technical Engineer - EP - Sevilla
Abbott Laboratories —Madrid, Madrid provincia
- Jornada completa
- Marketing
- Inglés
- Habilidades de comunicación
1d
Business Development Manager (Dental/Medical Devices)
Medilnt —Madrid, Madrid provincia
- Hasta 800 € al mes
- Media jornada
- Español
- Inglés
- Máster
Solicitud rápida
International Product Manager | Endodontics
Henry Schein España S.L. —Madrid, Madrid provincia
- 41.000 € al año
- Jornada completa
- Trabajo híbrido
- Español
- Marketing
- Inglés
Project Manager
Persei vivarium —Madrid, Madrid provincia
- PMP
- Project management
- Habilidades organizativas
Solicitud rápida
Market Development Specialist
Medtronic —Madrid, Madrid provincia
- De 41.600 € a 62.400 € al año
- Jornada completa
- Español
- Ventas
- Inglés

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Regulatory Affairs & Quality Assurance Manager (RA/QA Manager)

Medilnt
Poligono Industrial Alcobendas, Madrid provincia

Solicitud rápida

Detalles del empleo

Media jornada
Desde 800 € al mes

Cualificaciones

Español
Inglés
Farmacia

Descripción completa del empleo

Key Responsibilities:

1. Regulatory Affairs Management

Compliance Verification: Conduct rigorous reviews of Technical Files from international manufacturers to ensure full alignment with MDR 2017/745 and valid CE marking requirements.
Product Registration: Lead the end-to-end registration process in relevant databases and act as the primary point of contact for AEMPS to secure necessary product authorizations.
Labeling & IFU Oversight: Supervise all product labeling and Instructions for Use (IFU) to ensure strict compliance with Spanish language requirements and legal mandates (e.g., batch numbers, expiry dates, and standardized symbols).
Regulatory Intelligence: Proactively monitor updates in EU and Spanish medical device regulations, providing timely impact assessments and strategic recommendations to senior management.

2. Quality Management System (QMS) Oversight

ISO 13485 Implementation: Design, document, and execute a robust Quality Management System in strict accordance with ISO 13485 standards.
Supplier Qualification: Perform technical evaluations and audits of manufacturers and suppliers to ensure they meet stringent medical-grade quality and safety standards.
Incoming Quality Control (IQC): Oversee technical inspections of incoming goods, ensuring packaging integrity, storage condition compliance, and physical alignment with technical documentation.
Document Control: Establish and maintain a rigorous archival system for all technical files, certifications, and inspection reports to ensure data integrity and traceability.

3. Post-Market Surveillance, Traceability & Compliance

· Full Traceability Management: Implement and manage a comprehensive traceability system to track products from arrival (Lot/Batch Number) through to final delivery to the end-user (clinics/dentists).

· Complaint Handling & Investigation: Manage the end-to-end process for customer complaints, including technical investigation, root cause analysis, and reporting to manufacturers and regulatory bodies when required.

· Recall & Risk Management: Develop and execute operational protocols for rapid product recalls in the event of technical defects or mandatory orders from health authorities.

· Post-Market Surveillance (PMS): Drive the collection and analysis of real-world product performance data to generate periodic reports and ensure continuous product safety.

· Authority Liaison & Audit Readiness: Serve as the technical lead and official liaison during inspections by AEMPS and health authorities in Madrid; maintain constant “Audit Readiness” for both scheduled and unannounced inspections.

Qualifications:

· Strong foundation in regulatory affairs for medical devices, including practical experience with EU MDR, CE marking, and product registration processes.

· Quality management skills, such as implementing and maintaining QMS (e.g., ISO 13485), managing audits, CAPA, and document control.

· Analytical and organizational skills, including the ability to interpret regulations, assess compliance risks, and manage multiple projects and deadlines.

· Communication and collaboration skills, with the ability to work effectively with international manufacturers, internal teams, and regulatory bodies.

· Relevant academic background, such as a degree in biomedical engineering, pharmacy, life sciences, or a related field.

· Proficiency in Spanish and English, both written and spoken, for regulatory correspondence and technical documentation.

· Previous experience in regulatory affairs and/or quality assurance within the medical device or dental device sector is highly beneficial.

· Detail-oriented mindset, commitment to ethical practices, and readiness to work on-site in Madrid in a structured, compliance-driven environment.

Job Type: Part-time

Pay: From 800.00€ per month

Work Location: In person

Solicitud rápida

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biomedical engineering empleos en poligono industrial alcobendas, md

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