Diagnostic Regulatory Affairs IH / Operations Specialist

Grifols Shared Services North America, Inc; Sant Cugat del Vallès; On-site; EUR 40,000 - 65,000; Full time

Job summary

Grifols Shared Services North America, Inc busca un Especialista en IH/Regulatory Affairs para unirse al departamento de Regulatory Affairs diagnóstico. Será responsable de preparar expedientes técnicos, presentaciones y respuestas a autoridades regulatorias a nivel mundial, coordinando con I+D, fabricación y QA.

Se valorará experiencia en inmunohematología, habilidades analíticas y dominio de español e inglés.

Qualifications

• Licenciatura en Ciencias de la Salud o ingeniería.
• Experiencia en RRAA o departamentos técnicos dentro de la industria farmacéutica.
• Experiencia en inmunohematología deseable.
• Habilidades analíticas, atención al detalle y capacidad de resumir y evaluar.
• Nivel avanzado de español y inglés (C1) y MS Office (Excel).

Responsibilities

• Preparar y enviar expedientes de registro y/o renovación y/o cambios/variaciones de productos.
• Preparar documentación técnica basada en insumos de I+D.
• Coordinar la preparación de documentos para envíos regulatorios con I+D, fabricación y QA.
• Definir y guiar la interpretación de requisitos regulatorios y normas mundialmente.
• Preparar y responder a preguntas de autoridades sanitarias.

Skills

Analytical skills

Attention to detail

MS Office (Excel)

Spanish (C1)

English (C1)

Education

Bachelor's degree in Health Sciences or engineering

Tools

MS Office

Job description

¿Te gustaría un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y comercializamos medicamentos, soluciones y servicios innovadores en más de 110 países y regiones.

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

Mission

We are looking for an Immunohematology (IH) / Operations Regulatory Affairs Specialist to join Diagnostic Regulatory Affairs department. The RRAA Specialist will be responsible for the preparation of technical documentation, submission, following up and controlling of product registration and/or renewal, variations dossiers, as well as giving support to Regulatory transversal project.

What your responsibilities will be

• Prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.
• Prepare technical documentation based on the R&D inputs.
• Coordinate the preparation of the documents needed for regulatory submissions with R&D, manufacturing and QA departments.
• Define and provide guidance on the interpretation and application of regulatory requirements and standards worldwide.
• Prepare and send official responses to any Health Authority questions.
• Review and assess regulatory impact on product or manufacturing changes.
• Adapt licenses to current regulations.
• Manage/coordinate the delivery of product samples or labels related to product registration/renewal/change processes.
• Revise, approve and/or coordinate packaging material.
• Write and Manage SOPs.
• Review technical documents to ensure coherence and compliance with regulatory requirements.
• Assist commercial teams with regulatory documentation for tenders and customers

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 accommodation may be made to enable individuals with disabilities to perform the essential functions).

• You have a Bachelor's Degree in Health Sciences or engineering.
• You have been working in RRAA or technical departments within the pharmaceutical industry.
• You have experience in immunohematology, which is highly desirable.
• You have analytical skills, attention to detail, and ability to summarize and evaluate.
• You have Advanced level of Spanish and English (C1) and of MS Office (Excel).

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.

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.

Flexibility for U Program

Hybrid Model

Flexible schedule

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

Contract of Employment

Permanent position

Location

Sant Cugat del Vallès.

Conoce más sobre Grifols (http://www.grifols.com/es/web/international/home)