Regulatory Affairs Specialist (Diagnostic, IVD)

Ubicación: 

Sant Cugat del Valles, ES

Tipo de Contrato:  Indefinido tiempo completo
Área:  Registros
Número de solicitud de puesto:  483762

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

 

The Regulatory Affairs Specialist will be responsible of the preparation of technical documentation, submission and following up of product registration and/or renewal, variations dossiers, as well as other regulatory documentation, in our Diagnostic Business Unit. 

 

 

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 the regulatory requirements for the products
  • Prepare and send official responses to any Health Authority questions.
  • Review and assess regulatory impact for product or manufacturing changes.
  • Adapt licenses to current regulations.
  • Manage/coordinate the delivery of product samples or labels related with 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. 

 

 

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 accommodations 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 R&D or technical departments
  • You have experience in immunohematology, highly desirable.
  • You have experience in research: PhD, Postdoc
  • You have Advanced level of Spanish and English (C1) and of MS Office (Excel).
  • You have analytical skills, attention to detail, and ability to summarize and evaluate.

 

 

What we offer

 

It’s a brilliant opportunity for someone with the right talents.

Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We’ll help you grow professionally.

 

 

Information about Grifols is available at www.grifols.com. If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.

We look forward to receiving your application.

 

Grifols is an equal opportunity employer.

 

Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.

Benefits package

Contract of Employment: Permanent position

Flexibility for U Program: 2 days remote working

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Location: SPAIN : España : Sant Cugat del Valles:SC4 

 

Learn more about Grifols