Mecànic/A Oficial De 1A — Diagnòstic I Revisions

Midas España; Lérida; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Hybrid/Remote work

Job summary

Grifols is seeking an Immunohematology (IH) / Operations Regulatory Affairs Specialist to join the Diagnostics Regulatory Affairs team in Sant Cugat del Vallès. You will prepare regulatory dossiers, coordinate submissions, and ensure compliance across regions with R&D, manufacturing, and QA support.

Key requirements include a health sciences or engineering degree, experience in RRAA or pharma, and strong English/Spanish (C1) with MS Office proficiency.

Qualifications

• ³Bachelor's degree in Health Sciences or engineering.
• ³Experience in RRAA or technical departments within the pharmaceutical industry.
• ³Experience in immunohematology is highly desirable.
• ³Strong analytical, attention to detail, and ability to summarize and evaluate information.

Responsibilities

• Prepare registration, renewal, and changes/variations dossiers for relevant products.
• Develop technical documentation based on R&D inputs.
• Coordinate regulatory submissions with R&D, manufacturing and QA.
• Provide guidance on interpretation of regulatory requirements worldwide.
• Respond to Health Authority questions with official submissions.
• Review regulatory impact on product or manufacturing changes.

Skills

Analytical skills

Attention to detail

Summarize & evaluate

Spanish (C1)

English (C1)

MS Office

Excel

Education

Bachelor's degree in Health Sciences or engineering

Tools

MS Office

Excel

Job description

Diagnostic Regulatory Affairs IH / Operations Specialist

¿Te gustaría unirte a 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.

We believe in diverse talent and want to remove any barriers that may hinder your participation. Grifols is an equal opportunity employer.

Benefits package

Contract of Employment: Permanent position.
Location: Sant Cugat del Vallès.
Type: Indefinido tiempo completo.
Job Category:

Position Snapshot

• Location: Nestlé Internal Audit IT Hub, Barcelona
• Stream: Nestlé Internal Audit
• Type of Contract: Permanent contract
• Type of work: Hybrid/Remote
• Travel required: 40-50% of time (flexible)
• Work Language: Fluent Business English