Regulatory Compliance Specialist

Grifols Shared Services North America, Inc; Parets del Vallès; Híbrido; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

Grifols, un leader mondial dans le domaine des médicaments dérivés du plasma, recherche un Regulatory Compliance Specialist pour rejoindre son équipe à Parets del Vallès. Le candidat idéal aura un diplôme en sciences de la santé, 2 ans d'expérience dans l'industrie pharmaceutique et une connaissance approfondie des règlements européens. Ce poste offre un environnement de travail flexible avec des opportunités de développement professionnel dans une entreprise engagée en faveur de la diversité et de l'inclusion.

Servicios

Horaires flexibles

Travail à distance 2 jours par semaine

Programme de développement professionnel

Formación

• Min. 2 ans d'expérience en réglementation dans l'industrie pharmaceutique.
• Connaissances des règlements européens (U.S. : FDA) et de la structure eCTD.
• Anglais avancé requis.

Responsabilidades

• Préparer et revoir des dossiers d'enregistrement et des documents techniques.
• Coordonner les informations des différents départements.
• Gérer la database Eudamed pour les dispositifs médicaux.

Conocimientos

Connaissances réglementaires européennes

Compétences en communication

Compétences analytiques

Précision

Travail en équipe

Educación

Diplôme en sciences de la santé

Descripción del empleo

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.

Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a Regulatory Compliance Specialist like you, joining the Regulatory team at Laboratorios Grifols SA.

Your role mission: prepare and review the required documentation for registration dossiers and technical files related to products of Laboratorios Grifols SA.

What your responsibilities will be

• Gather information from various departments to complete registration dossiers:

Coordinate the documentation required by the Regulatory Department for the preparation of registration dossiers or technical files.

Organize deliverables meetings with different departments.

Collect and review all information from the various departments.

In case of serialization, coordinate the information to be indicated on the product.

• Collect and/or review the necessary information for the preparation of PQR/APR and/or Annual Reports.:

Draft the Annual Report (AR), when applicable.

Review information to prepare the PQR.

• Review internal documentation for regulatory impact:

Review requests for creation or modification of production documentation to assess regulatory impact.

Communicate with involved departments and manage information received from the Regulatory Department regarding authorization modifications or new marketing authorizations.

• Review / Create Quality System documentation:

Create and review Standard Operating Procedures (SOPs) for the department and/or related to regulatory requirements.

Manage the European database of medical devices, Eudamed.

• Manage Eudamed (register LG, manage users, assign user roles, etc.).

• Register, update, and periodically review information in the Economic Operators module, Product. Registration module, and UDI module of Eudamed.

Maintain the GUDID database.

• Participate in change controls and projects:

Evaluate the regulatory impact of various change controls before acceptance.

Draft change controls initiated by the department.

Act as Project Manager for projects arising from regulatory changes.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

• You have a Bachelor's degree in Health Sciences (Pharmacy, Chemistry, Biotechnology, Biomedicine or similar).

• You have a minimum of 2 years of experience in Regulatory within pharmaceutical industry and/or medical devices.

• You have high knowledge in European regulations (UE) 2017/745 (medical devices), 2001/83/CE (medicines) and/or other applicable region regulations (i.e., USA: FDA 21 CFR Part 820 for medical devices, FDA 21 CFR Part 314 for medicines).

• You have experience in evaluating changes through the available guidelines for medicines and medical devices.

• You have knowledge of eCTD structure.

• Your English level is advanced.

• You have excellent communication skills.

• You have analytical and precision skills.

• You have the ability to work in a team.

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!

We look forward to receiving your application!

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.

Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).

Benefits package

Contract of Employment: Permanent position

Flexibility for U Program: 2 days remote working

Location: Parets del Vallès

www.grifols.com

Learn more about Grifols

Req ID: 529726

Type: Indefinido tiempo completo

Job Category: AREA TECNICA OPERACIONAL