IH Regulatory Diagnostics & Operations Specialist

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

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.