Regulatory Affairs Specialist Clinical Diagnostic

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. 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.

At Grifols, we are looking for a Regulatory Affairs Specialist to ensure global regulatory compliance by managing regulatory dossiers, technical documentation, product renewal and changes, and communication with authorities, to ensure product safety and effectiveness.

Key Responsibilities

• Ensure compliance with regulatory requirements throughout the life cycle of products, from development to marketing.
• Review documentation related to product design taking into account applicable regulations.
• Create regulatory dossiers worldwide and verify compliance with regulatory requirements.
• Perform the review of labeling in accordance with current regulations.
• Supervise the consistency of reports that support the registration of products in accordance with current standards.
• Draft letters and Technical Documentation that should be submitted to Regulatory Authorities or other Certifying Bodies.
• Participate in the preparation of responses to deficiency letters sent by Regulatory Authorities/Notified Bodies.
• Determine the Regulatory Impact of changes in Products, Manufacturing Processes and Facilities.
• Keep up to date of the standards and regulations applicable to the Diagnostic Business Unit products.
• Draft Technical Bulletins related to labeling changes that should be shared with the customers.
• Be involved in internal and external audits as needed.

Requirements

• Bachelor's degree in Health Sciences (Biomedicine, Biotechnology, Biology, Biochemistry or related).
• Minimum 2 to 3 years of experience working in Regulatory Affairs.
• Experience or participation in the development of immunoassays and/or molecular biology products (IVD/MD products).
• Advanced level of English (C1.1).
• Knowledge and application of work standards (GMP, SOP, INS, GLP, ISO 13485, according to defined procedures).
• Excellent communications skills and the ability to work in cross-functional teams.
• Organized, proactive and dynamic person with the capacity for continuous learning.