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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, quality management system, and environmental management system in Iberica. This role will ensure the safety of healthcare professionals and patients who come into contact with the company's medical device products.

Key Responsibilities

  • Collaborate in the management and maintenance of regulatory, vigilance, and quality management processes, including product field actions, holds, SOPs, audits, CAPAs, OEMs, training, product registration, and certifications.
  • Maintain a good relationship with Competent Authorities and internal and external customers.
  • Focus on continuous improvement and participate in activities across the European team.
  • Ensure that systems and actions are put in place according to European regulations, country-specific legislation, and quality management certification requirements.
  • Provide technical and scientific support.

Requirements

  • Fluent in English and Spanish. Portuguese is 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, ability to prioritize and organize own workload, and ability to analyze data and statistics.

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