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Diagnostic Quality & Regulatory Affairs Operations Specialist

Hybrid in Sant Cugat del Vallès·Added 24 days ago (last checked 2 Nov)

Grifols

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Our summary

Work mode: Hybrid, Sant Cugat del Vallès
Spanish: Fluent
English: Required
Education: University degree

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Skills

Requirements

What we're looking for

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 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).

Nice to have

You have experience in immunohematology, which is highly desirable.

Pay & benefits

What you'll get

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.

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).

The role

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 you'll do

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

How you'll work

Contract of Employment: Permanent position

Location: Sant Cugat del Vallès.

www.grifols.com

Location: SPAIN : España : Sant Cugat del Valles:

Learn more about Grifols

Hiring process

4 steps2 interviews

Job search
Start your search on the Grifols careers site or join the Talent Community to stay up to date with the latest jobs posted.
Application
Screening call
With recruitment team · Phone call
If you are shortlisted, the team contacts you for a short screening call about your motivation, skills and experience, and to go into the key details of the role.
Interviews
30–45 min
There are usually two or more interviews of 30 to 45 minutes each; your interviewer will assess your skills and aptitudes with questions focused on the role and your experience.
Decision and offer
Pre-onboarding
Once you accept the offer, the pre-onboarding process begins, with all the information and resources you need for a smooth transition to your new role.

Three people support you: a talent acquisition lead, a hiring manager and an HR manager.

About Grifols

Grifols is a global healthcare company headquartered in Barcelona, Spain, specializing in the development and production of plasma-derived medicines, transfusion medicine, and diagnostic solutions. With operations in over 100 countries and a workforce of more than 20,000 employees, it is one of the world's leading producers of plasma-based therapies, treating chronic and rare diseases. The company operates a vast network of plasma donation centers and manufacturing facilities, making it a key player in the biopharmaceutical industry.

In Spain, Grifols maintains its global headquarters in Barcelona and operates major production and R&D sites in the Catalonia region, including facilities in Parets del Vallès and Sant Cugat del Vallès. The company is deeply rooted in Spain, offering a wide range of roles from laboratory and manufacturing positions to IT, engineering, and corporate functions. For international professionals, Grifols provides a multicultural work environment, opportunities in a highly regulated and innovative sector, and the chance to work in a company that is a global leader in its niche, with Spanish as a common working language alongside English.

Industry: Pharma
Founded: 1909
Employees: 20,000–25,000
Headquarters: Barcelona, Spain
In Spain: Barcelona, Parets del Solès, Sant Cugat del Vallès

Good to know if you are moving

Grifols is headquartered in Barcelona, Spain, and is one of the largest companies in the Catalan region, offering a strong local presence and career opportunities.
The company operates in a highly regulated and innovative sector, providing roles in R&D, manufacturing, and IT, which can be attractive for professionals with experience in biotech or pharma.
While Spanish is the primary language in many roles, the company's global nature means English is often used, especially in IT, corporate, and international positions.
Grifols has a strong commitment to employee development, with trainee programs and continuous learning opportunities, as seen in the STEM Trainee Program IT QA.
The company's global footprint includes operations in the US, Europe, and Asia, offering potential for international mobility within the organization.

In their own words

About the company & team

Would you like to join an international team working to improve the future of the healthcare sector? Do you want to contribute to improving the lives of millions of people? Grifols is a global healthcare company that since 1909 has been improving the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and we 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 opportunities, fostering an inclusive environment where diversity makes us outstanding.

All open roles at Grifols