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Senior Regulatory Affairs Specialist

hace 2 meses

Alcobendas, Madrid, España Stryker A tiempo completo

Job Summary

The Senior Regulatory Affairs Specialist will be responsible for implementing and improving Stryker's regulatory and post-market surveillance system, the Quality Management system, and the Environmental management system in Iberica.

Key Responsibilities

  • 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, for proper investigation by Stryker's manufacturing divisions.
  • Maintain a good relationship with Competent Authorities and internal customers.
  • Develop and execute tasks to maintain company compliance with current and applicable laws, guidelines, and Stryker SOPs related to Quality and Regulatory, including ISO 9001.
  • Organize, follow up, and execute all needed tasks at the RAQA Teams/function of the distribution business in the area, ensuring that the area meets all Quality/Regulatory requirements and Industry standards.
  • Take controlled decisions in case of emergencies, when the Manager is not available.
  • Collaborate with the EU team, taking care of activities at EU level assigned to him/her.

Requirements

  • Fluent in English & Spanish. Portuguese will be a plus.
  • Degree graduate (Science/engineering/business fields) or no less than 2-3 years 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 & customer service skills.
  • Ability to prioritise and organise own workload.
  • Ability to analyse data and statistics.