Regulatory Affairs Specialist
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.
We are looking for a Immunohematology (IH) Regulatory Affairs Specialist to join Diagnostic Regulatory Affairs department.
The RRAA 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.
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 RRAA or technical departments within the pharmaceutical industry.
* You have experience in immunohematology, highly desirable.
* 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 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).
Benefits Package
Professional Group: 6
Contract of Employment: Permanent position
Location: Parets del Vallès
www.grifols.com
Location: SPAIN : España : Parets del Valles : [[cust_building]]
Learn more about Grifols
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Contract
Job function
* Job function
Legal
* Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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