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Regulatory Affairs Specialist
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Grifols2 days ago Be among the first 25 applicantsJoin to apply for the
Regulatory Affairs Specialist
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GrifolsWould 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.We are looking for an Immunohematology (IH) Regulatory Affairs Specialist to join our Diagnostic Regulatory Affairs department.The RRAA Specialist will be responsible for the preparation of technical documentation, submission, and follow-up of product registration and/or renewal, variations dossiers, as well as other regulatory documentation.What Your Responsibilities Will Be
Prepare and send registration, renewal, and variation dossiers of relevant products.Prepare technical documentation based on R&D inputs.Coordinate the preparation of 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 Health Authority questions.Review and assess regulatory impact for product or manufacturing changes.Adapt licenses to current regulations.Manage/coordinate delivery of product samples or labels related to registration, renewal, or change processes.Revise, approve, and/or coordinate packaging materials.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.Bachelor's Degree in Health Sciences or engineering.Experience in RRAA or technical departments within the pharmaceutical industry.Experience in immunohematology is highly desirable.Advanced level of Spanish and English (C1) and proficiency in MS Office (Excel).Analytical skills, attention to detail, and ability to summarize and evaluate.What We Offer
This is a great opportunity to join Grifols, a company that values its employees and encourages professional development in an excellent working environment.Information about Grifols is available at www.Grifols.Com. If you are interested and meet the requirements for this exciting position, please apply!We are committed to diversity and removing barriers in our hiring process. If you require adjustments during our selection process, please inform us when applying. We are here to help.Grifols is an equal opportunity employer.Flexibility for U Program:
Hybrid ModelFlexible schedule:
Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with flexible start times).Benefits PackageProfessional Group:
6Contract:
Permanent positionLocation:
Parets del Vallès, SPAINSeniority level
Entry levelEmployment type
ContractJob function
LegalIndustries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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