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Regulatory Affairs Specialist Clinical Diagnostic

hace 2 meses

Gasteiz Vitoria, Álava, España Grifols A tiempo completo

Job Summary

Grifols is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring global regulatory compliance by managing regulatory dossiers, technical documentation, product renewal and changes, and communication with authorities.

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.
  • Determine the Regulatory Classification of products and applicable standards.
  • 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 for submission 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.
  • Stay up-to-date on standards and regulations applicable to the Diagnostic Business Unit products.
  • Draft Technical Bulletins related to labeling changes for sharing with customers.
  • Participate in internal and external audits as needed.

Requirements

  • Bachelor's degree in Health Sciences (Biomedicine, Biotechnology, Biology, Biochemistry, or related).
  • Minimum 2-3 years of experience working in Regulatory Affairs.