We're seeking a Nucleic Acid Testing (NAT) Regulatory Affairs Specialist to join our Diagnostic Regulatory Affairs team at Grifols, a global healthcare company dedicated to improving lives worldwide.
About Our Team
At Grifols, we believe diversity adds value to our business, teams, and culture. We're committed to equal employment opportunities that foster an inclusive environment.
Your Key Responsibilities
* Prepare and submit registration, renewal, and change dossiers for relevant products.
* Develop technical documentation based on R&D inputs.
* Coordinate document preparation for regulatory submissions with R&D, manufacturing, and QA departments.
* Determine regulatory requirements for products.
* Respond to Health Authority questions with official statements.
* Assess regulatory impact for product or manufacturing changes.
* Update licenses according to current regulations.
* Manage the delivery of product samples or labels related to product registration/renewal/change processes.
* Review and approve packaging materials.
* Create and manage SOPs.
* Verify technical documents for coherence and compliance with regulatory requirements.
About You
* You hold a Bachelor's Degree in Health Sciences or engineering.
* You have experience working in RRAA or technical/R&D departments within the pharmaceutical industry.
* You possess a scientific background.
* You have advanced levels of Spanish and English (C1) and MS Office (Excel).
* You possess analytical skills, attention to detail, and ability to summarize and evaluate.
What We Offer
This is a fantastic opportunity to grow your career with Grifols. We recognize our employees as our greatest asset and strive to maintain a positive work environment that encourages professional development.
Grifols offers a hybrid model with flexible scheduling: Monday-Thursday 7am-10am and 4pm-7pm, Friday 8am-3pm. Our benefits package includes a permanent contract of employment.