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Senior Regulatory Affairs Specialist

hace 2 meses

Alcobendas, Madrid, España Stryker Group A tiempo completo
About the Role

The Stryker Group is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Madrid. As a key member of our Quality Management team, you will be responsible for implementing and improving our regulatory and post-market surveillance system, ensuring the safety of healthcare professionals and patients who come into contact with our medical device products.

Key Responsibilities
  • Collaborate with cross-functional teams to maintain and improve our regulatory, vigilance, and quality management systems.
  • Ensure compliance with current and applicable laws, guidelines, and Stryker SOPs related to Quality and Regulatory, including ISO 9001.
  • Develop and execute tasks to maintain company compliance, including product field actions, holds, SOPs, audits, CAPA, OEM, training, product registration, and certification.
  • Maintain excellent relationships with Competent Authorities, internal and external customers, and collaborate with the EU team on assigned activities.
  • Ensure systems and actions are in place according to European regulations, country-specific legislation, and quality management certification requirements.
Requirements
  • Fluent in English and Spanish, with Portuguese as 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 14001, and MDD vigilance and notification processes.
  • Good communication and team working skills, analytical and customer service skills, ability to prioritize and organize workload, and analyze data and statistics.