Quality & Regulatory Affairs Manager

Elemed; Barcelona; Híbrido; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

Una empresa líder en tecnología quirúrgica busca un Regional QARA Lead en Barcelona. La posición requiere liderazgo en QA y regulaciones de dispositivos médicos y experiencia en recolección de datos clínicos. Se espera fluidez en español e inglés, y el trabajo es presencial 3 días a la semana. Esta es una gran oportunidad para unirse a un equipo enfocado en garantizar la disponibilidad y cumplimiento de dispositivos médicos innovadores.

Servicios

Mentoría 1 a 1

Oportunidades de desarrollo profesional

Ambiente diverso e inclusivo

Formación

• Al menos 5 años en QA o RA en la industria de dispositivos médicos.
• Experiencia en la gestión del sistema de calidad.
• Habilidades en recolección de datos clínicos.

Responsabilidades

• Mantener el sistema de gestión de calidad de la organización española.
• Asegurar que el portafolio de dispositivos sea compliant.
• Liderar procesos de recolección de datos clínicos.

Conocimientos

Experiencia en regulaciones de dispositivos médicos

Fluidez en español e inglés

Liderazgo en proyectos de QA

Descripción del empleo

The company

¿Es usted el solicitante adecuado para esta oportunidad? Descúbralo leyendo el resumen del puesto a continuación.

Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are always accessible to patients and surgeons on the market? Here is a rare and great opportunity to join an international leader in surgical technology and be part of this company’s regional growth strategy in Spain and Portugal and be visible at the EMEA-level. As the Regional QARA Lead for the IBERIAN region, you will be based at their Spain branch office in Barcelona, where they have centralised sales, marketing, customer success teams all in one place.

This is a company-critical role and your past experiences in registrations can help the company to reach their business goals for the EMEA region.

You will be responsible for the quality system of the sales office in Barcelona as well as supporting the registrations for Spain. Furthermore, you are part of the EMEA Quality Assurance and Regulatory affairs team, for this region you will be responsible for collecting clinical data from surgeons to assist the HQ in the US with clinical surveillance.

In this role you will report directly to the Sr Director Quality Assurance and Regulatory Affairs International

Maintain the Quality Management System for their Spanish Organization

Work with the Regional Commercial leader to ensure the medical device portfolio remain commercially available and compliant

Leading clinical data collection and surgeon feedback processes for submission and PMCFs

Prepare and lead the quality management review meetings

Training and coaching people in RAQA functions in other EMEA offices on the procedures and processes

Identify local regulatory requirements and lead impact assessment which is driving quality management system changes

Execute Local regulatory registrations where necessary

EMEA regulatory affairs activities concerning importer and authorized representative requirements

At least 5 years in a quality assurance or regulatory affairs role in the medical device industry

Led the RAQA operations or projects for medical devices

Fluent written & spoken in Spanish and English (bonus if Portuguese and Catalan as well)

Office-presence 3 days per week in Barcelona city-centre

We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.

#At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.

Learn and develop as a regulatory, quality or clinical professional with 1 : 1 mentorship from a highly experienced mentor. Our mentors are some of the most inspirational and talented senior professionals in the medical device and IVD industry. Join hundreds of fellow regulatory, quality and clinical professionals in Elemed’s RQC Network.

We are an equal opportunity employer and value diversity at our company