20 publicaciones de empleo destacadas en "regulatory affairs" (¡Están contratando!)

Quality & Regulatory Affairs Specialist (Portuguese market)
Zimmer Biomet —En remoto
- Jornada completa
- Teletrabajo
- Español
- Inglés
- Máster
Regulatory Affairs Specialist
Rieka Talent —Castelló d'Empúries, Girona provincia
- Jornada completa
- Español
- Inglés
- Máster
Solicitud rápida
POSITION REGULATORY AFFAIRS SPECIALIST
FARMHISPANIA GROUP —Barcelona, Barcelona provincia
- Inglés
- APIs
Associate Specialist, Regulatory Affairs HUB SoE
Abacus Medicine Group —Madrid, Madrid provincia
- Trabajo híbrido
- Español
- Doctorado
- Inglés
Quality Assurance & Regulatory Affairs Specialist - Temporary position
Ferring Pharmaceuticals, Inc. —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Máster
1d
Equipment Compliance Trainee (Regulatory Affairs)
Ecolab Inc. —Barcelona, Barcelona provincia
- Jornada completa
- Microsoft Powerpoint
- Microsoft Excel
- Inglés
14d
Regulatory Affairs Trainee
Ferrer —Barcelona, Barcelona provincia
- Jornada completa
- Trabajo híbrido
- Bases de datos
- Contrato en prácticas
Regulatory Affairs Specialist
MartiDerm —Cervelló, Barcelona provincia
- Grado
Associate Director, Regulatory Affairs – Clinical Trials (FSP Strategy & Business Development)
Thermo Fisher Scientific —En remoto
- Jornada completa
- Teletrabajo
- Habilidades de presentación
- Grado
TEMPORARY REPLACEMENT: CHEMICALS TECHNICIAN FOR REGULATORY AFFAIRS (NON FOOD-NON PHARMA)
Eurofins —Barcelona, Barcelona provincia
- De 25.000 € a 30.000 € al año
- Incorporación inmediata
- Español
- Inglés
- Microsoft Office
- Flexibilidad horaria
Solicitud rápida
Manager, Regulatory Affairs HUB SoE
Abacus Medicine Group —Madrid, Madrid provincia
- Trabajo híbrido
- Inglés
- Oficina
- Máster
Técnico/a de Regulatory Affairs & Product Safety
NUFRI —Mollerussa, Lleida provincia
- Jornada completa
- Inglés
- Grado
- Habilidades organizativas
Solicitud rápida
9d
Regulatory Affairs Manager
Revolut —En remoto
- Jornada completa
- Teletrabajo
- Inglés
- Oficina
- Administración y dirección de empresas
Medical Affairs Trainee - Respiratory
Chiesi Farmaceutici —Barcelona, Barcelona provincia
- De lunes a viernes
- Trabajo híbrido
- Microsoft Powerpoint
- Microsoft Excel
- Inglés
- Flexibilidad horaria
5d
TÈCNIC/A REGULATORY AFFAIRS
AVINENT —Santpedor, Barcelona provincia
- Jornada completa
- Español
- Inglés
Solicitud rápida
R&D Specialist – Injectable Medical Devices | ISO 13485 Environment
Rieka Talent —Castelló d'Empúries, Girona provincia
- Jornada completa
- Trabajo híbrido
- Español
- Inglés
- Máster
Solicitud rápida
3d
Quality Assurance Specialist
Uriach Italy —Sant Cugat del Vallès, Barcelona provincia
- Español
- Inglés
- Grado
Solicitud rápida
REGULATORY AFFAIRS MANAGER
Almirall —Sant Feliu de Llobregat, Barcelona provincia
- Jornada completa
- Inglés
- Project management
- Grado
Regulatory & Quality Lead – AI IVD Diagnostics
SpotLab —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Español
- Inglés
- Bachillerato
Solicitud rápida
Técnico/a Regulatory (I+D+i)
Grupo Ubesol —Ulldecona, Tarragona provincia
- Trabajo híbrido
- Inglés
- Bases de datos
- Habilidades organizativas
- Formación continua
- Flexibilidad horaria
Solicitud rápida

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Quality & Regulatory Affairs Specialist (Portuguese market)

Zimmer Biomet -
En remoto

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Detalles del empleo

Jornada completa

Cualificaciones

Español
Inglés
Máster
Portugués

Descripción completa del empleo

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

As a QARA Specialist, you will be part of the EMEA Quality Commercial & Distribution Team within the Commercial Organization.

You will be responsible for supporting the Quality Assurance & Regulatory Affairs function of Portugal by:

ensuring compliance with the requirements of ISO 13485 Quality Management System, appropriate company policies and any other ISO if applicable or required in country (i.e ISO9001, ISO14001, ISO37001 e.t.c).
ensuring local organization comply with industry specifications, standards and European as also in country regulations (i.e European Medical Device Regulation (EU) 2017/745).

How You'll Create Impact

Quality Management System (QMS)

Support implementation, development, maintenance, and improvement of the local QMS (Quality Management System)
Drive CAPAs and Issue Evaluations
Participate, provide support and manage quality reviews
Support with QA/RA standardization of processes
Work on continuous improvement of our processes

Regulatory Compliance

Be responsible for product registration, notifications, or renewals and/or regulatory clearance in assigned market in accordance with local in-country regulatory requirements
Be main contact for the local competent authority. Act as a local regulatory responsible person
Provide regulatory support to commercial and in-country local commercial teams
Manage and maintain regulatory documentation, ensuring it complies with applicable regulatory standards and guidelines
Assist with effective, consistent, and reliable Product Surveillance

Complaint Handling

Be responsible for complaint handling (submission, coordination of product return, follow-up investigation)

Field Actions (Recalls)

Liaise with FSCA team and regional stakeholders to initiate recalls
Handling the Field Safety Notices to the affected customers, reports the reconciliation of products and customers acknowledgment to the PMS team or FSCA Team
Be responsible for the handling of instructed actions like Field Notices (FN), Product Holds

Audits internal/ external

Plan, support and join the internal and external audits
Ensure the Audit preparation activities and support for auditees. Ensure follow-up on Audits (Internal/EMEA/External) as appropriate and required by the internal procedures

What Makes You Stand Out

Ability to handle high volume of correspondence and prioritize work accordingly
Ability to work independently and collaboratively in a team-oriented environment.
Ability to prepare high quality, clear communication materials to the appropriate audience
Excellent communication and interpersonal skills.
Ability to work with accuracy and precision.
Diplomacy and tenacity.
Discretion and confidentiality
Ability to work in a multinational team.
Ability to adapt to changing environment.

Your Background

You hold a B.S. or M.S. degree in biomedical/clinical engineering, pharma, biological or medical science (or equivalent experience) alongside with 5+ years’ experience in registration/notification activities and/or quality assurance in medical devices area.

You have a comprehensive knowledge of regulatory requirements and legislation in Portugal.

In addition you are fluent in Portuguese, Spanish and English.

Travel Expectations

Up to 5%.

The role is ideally based in Barcelona, Spain. Other locations in Spain or in Portugal could be considered.

EOE/M/F/Vet/Disability

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POSITION REGULATORY AFFAIRS SPECIALIST

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TEMPORARY REPLACEMENT: CHEMICALS TECHNICIAN FOR REGULATORY AFFAIRS (NON FOOD-NON PHARMA)

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Técnico/a de Regulatory Affairs & Product Safety

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Medical Affairs Trainee - Respiratory

TÈCNIC/A REGULATORY AFFAIRS

R&D Specialist – Injectable Medical Devices | ISO 13485 Environment

Quality Assurance Specialist

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