Regulatory Affairs Specialist Lab Automation

hace 5 días

Sant Cugat, Barcelona, España GRIFOLS, S.A. A tiempo completo

table.MiTabla { max-width: 1020px;important



Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and 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 that foster an inclusive environment.

What your responsibilities will be

  • Act as an interface with Regulatory Authorities/ Notified Bodies.
  • Determines the Regulatory Classification of the products and the applicable standards.
  • Create regulatory dossiers and verify compliance with regulatory requirements.
  • Coordinates the reviews of labeling in accordance with current regulations.
  • Supervises the consistency of the reports that support the registration of products in accordance with current standards (eg Technical Files CE, 510k, BLA, annual reports, etc).
  • Draft letters and Technical Technical Documentation that should be submitted to Regulatory Authorities or other Certyfing Bodies
  • Determines the Regulatory Impact of changes in Products, Manufacturing Processes and Facilities.
  • Is up to date of the standards and regulations applicable to the Diagnostic Business Unit products.
  • Draft Technical Documentation related to labeling changes that should be shared with the 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 accommodations may be made to enable individuals with disabilities to perform the essential functions).

  • Bachelor's Degree in Pharmacy, Chemistry, Biology, Biomedical Engineering, or a related Life Sciences/Scientific field.
  • Between 2-5 years of experience in technical and regulatory documentation. Prior experience with IVDR and FDA regulations within the Medical Device or IVD industry is highly valued.
  • Ability to act as a primary point of contact and lead submissions with international health authorities and Notified Bodies.
  • Methodical and detail oriented, with rigorous approach to ensuring regulatory compliance and technical accuracy.
  • Ability to work closely with cross-functional teams
  • Advanced level of English

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  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 

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).

Benefits package

Contract of Employment: Permanent position

Location: Sant Cugat del Vallès.

#LI-Hybrid

#LI-ER1

Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]] 

Learn more about Grifols

  • Regulatory Affairs Specialist Lab Automation

    hace 5 días

    Sant Cugat, Barcelona, España Grifols A tiempo completo

    table.MiTabla { max-width: 1020px;importantWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Sant Cugat, Barcelona, España Grifols A tiempo completo

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...

  • Regulatory Affairs Specialist

    hace 6 días

    Sant Cugat, Barcelona, España Grifols A tiempo completo

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Sant Cugat, Barcelona, España Grifols A tiempo completo

    table.MiTabla { max-width: 1020px;importantWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Sant Cugat, Barcelona, España GRIFOLS, S.A. A tiempo completo

    table.MiTabla { max-width: 1020px;important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived...

  • Public Affairs Specialist

    hace 2 semanas

    Sant Cugat, Barcelona, España Manpower España A tiempo completo

    Public Affairs SpecialistLocation:Sant Cugat, SpainContract:Temporary – 10 monthsSalary:€15.67 per hourWe are currently seeking aPublic Affairs Specialistto join the team of aleading global technology clientat one of its key hubs in Sant Cugat. This is an exciting opportunity to contribute to high-impact public affairs initiatives within a dynamic,...

  • Regulatory Affairs Technician

    hace 2 días

    Sant Cugat, Barcelona, España AB-BIOTICS A tiempo completo

    Studying scientific and legal documentsGathering, evaluation, organizing, managing and collating information in a variety of formats.Ensuring compliance with regulations set by the legal authorities as Medicines and Medical devices Regulatory Agency (AEMPS)Maintaining familiarity with company product rangesPlanning, undertaking, and overseeing product trials...

  • Customs & Regulatory Affairs Specialist

    hace 2 semanas

    Sant Just Desvern, Barcelona, España Bunge A tiempo completo

    Location: BarcelonaCity: Sant Just DesvernState: Barcelona (ES-B)Country: Spain (ES)Requisition Number: 42758BUNGEhas an exciting opportunity available for aCustoms & Regulatory Affairs Specialist. In this role, you will be responsible to support Customs, Excise Duties and Trade Compliance activities across the WE Countries, ensuring that all global...

  • Product Compliance Specialist

    hace 7 días

    Sant Cugat, Barcelona, España Win Systems International Holdings Inc. A tiempo completo

    Win SystemsWe are a global software company specializing in casino management solutions. With a robust and competitive product currently deployed in over 20 countries, we are proud to be a trusted technology partner for leading casino operators worldwide.We are currently looking for a Product Compliance Specialist to join our dynamic team. This role is...

  • Global Lead Counsel – Data Privacy, Regulatory Affairs

    hace 6 días

    Sant Quirze del Vallès, Barcelona, España ABB A tiempo completo

    Bei ABB unterstützen wir Industrien dabei, effizienter und nachhaltiger zu werden. Fortschritt ist bei uns keine Option, sondern selbstverständlich – für Sie, Ihr Team und die Welt. Als globaler Marktführer bieten wir Ihnen alles, was Sie brauchen, um diesen Wandel voranzutreiben. Der Weg dorthin ist nicht immer einfach – denn echtes Wachstum...