Senior Regulatory Affairs Specialist

hace 2 semanas

Madrid, Madrid, España Stryker Iberia S.L. A tiempo completo
About the Role

Stryker Iberia S.L. is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Madrid. As a key member of our Quality and Regulatory department, you will be responsible for ensuring the company's compliance with regulatory requirements and industry standards.

Key Responsibilities
  • Implement and improve Stryker's regulatory and post-market surveillance system, Quality Management system, and Environmental management system in Iberia.
  • Ensure the safety of healthcare professionals and patients by assuring that good distribution practices, regulations, and laws are fulfilled.
  • Manage an effective and efficient channel for customers to report product performance complaints, and investigate these complaints properly.
  • Maintain a good relationship with Competent Authorities and internal customers.
  • Collaborate with the EU team on activities at the EU level.
  • Manage and maintain Regulatory, Vigilance, and QMS processes, including Product Field actions, Holds, SOPs, Audits, CAPA, OEM, Training, Product Registration, and certifications.
Requirements
  • Fluent in English and Spanish, with Portuguese being a plus.
  • Degree graduate in Science, Engineering, or Business fields, or no less than 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, and MDD vigilance and notification processes.
  • Good communication and team working skills, analytical and customer service skills, and ability to prioritize and organize workload.
What We Offer
  • A dynamic and challenging work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

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