Senior Regulatory Affairs Specialist

hace 4 semanas


Madrid, Madrid, España Stryker Group A tiempo completo
Job Title: Senior Raqa Specialist

The Senior Raqa Specialist plays a crucial role in ensuring the safety and quality of Stryker's medical device products. Based in Madrid, this position is responsible for implementing and improving the company's regulatory and post-market surveillance system, quality management system, and environmental management system in Iberica.

Key Responsibilities:
  • Ensure compliance with current and applicable laws, guidelines, and Stryker SOPs related to quality and regulatory.
  • Collaborate with the EU team to manage and maintain regulatory, vigilance, and QMS processes.
  • Develop and execute tasks to maintain company compliance with industry standards and regulations.
  • Organize and follow up on tasks at the RAQA Teams/function of the distribution business in the area.
  • Take controlled decisions in case of emergencies.
Requirements:
  • Fluent in English and Spanish. Portuguese is a plus.
  • Degree graduate in science, engineering, or business fields.
  • At least 2-3 years of experience working in QA/RA for a medical device or pharmaceutical organization.
  • Proven expertise in ISO 9001 Quality Management Systems, ISO 14001, and MDD vigilance and notification processes.
  • Good communication and team working skills.
  • Ability to prioritize and organize own workload.

Stryker Group is a leading medical technology company committed to helping healthcare professionals improve patient outcomes. If you are a motivated and detail-oriented professional with a passion for quality and regulatory affairs, we encourage you to apply for this exciting opportunity.



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