Diagnostic Quality & Regulatory Affairs Operations Specialist

GRIFOLS, S.A.; Sant Cugat del Vallès; Híbrido; EUR 55.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid Model

Descripción de la vacante

Grifols is seeking an Immunohematology/Operations Regulatory Affairs Specialist to join the Diagnostic Regulatory Affairs team. You will prepare registration documents, coordinate global submissions, and provide regulatory guidance across R&D, manufacturing, and QA.

Strong analytical skills and fluency in Spanish and English are required, with a hybrid work model offered. The role focuses on adapting licenses to current regulations, responding to health authorities, and supporting commercial

Formación

• Bachelor's degree in Health Sciences or engineering.
• Experience in RRAA or technical pharma departments.
• Immunohematology experience is desirable.
• Analytical skills, attention to detail, ability to summarize/evaluate.
• Advanced level of Spanish and English (C1) and MS Office.

Responsabilidades

• Prepare and send registration/renewal/variations dossiers for relevant products.
• Prepare technical documentation based on R&D inputs.
• Coordinate regulatory submissions with R&D, manufacturing and QA.
• Interpret and apply global regulatory requirements and standards.
• Prepare official responses to Health Authority questions.
• Review regulatory impact on product/manufacturing changes.
• Adapt licenses to current regulations.
• Coordinate delivery of product samples/labels for registrations/changes.
• Review and approve packaging material; write/manage SOPs.
• Review technical documents for regulatory coherence.
• Assist commercial teams with regulatory docs for tenders.

Conocimientos

Spanish C1

English C1

MS Office

Analytical skills

Educación

Bachelor's in Health Sciences/Engineering

Descripción del empleo

Diagnostic Quality & Regulatory Affairs Operations Specialist

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 believe in diverse talent and want to remove any barriers that may hinder your participation.

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