Senior RAQA Specialist

The Job's Mission

• Based in Madrid, the Senior RAQA Specialist is responsible for implementing and improving Stryker’s regulatory and post market surveillance system, the Quality Management system and the Environmental management system in Iberica.
• The focus is on ensuring the safety of health care professionals and patients that come into contact with the company’s medical device products. This includes assuring that the good distribution practices, regulations and laws are fulfilling and managing 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 CAs.
• Develop and execute the needed tasks to maintain the company compliance with the current and applicable law, guidelines and Stryker SOPs related with Quality and Regulatory, which includes the ISO 9001.
• The job holder will organize, follow up and execute all the 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.
• The job holder will take controlled decisions in case of emergencies, when the Manager will be not available.
• The job holder will collaborate with the EU team, taking care of the activities at EU level that will be assigned to him/Her.

Key Activities & Accountabilities

• Collaborate in the management and maintenance of Regulatory, Vigilance and QMS processes: Product Field actions, Holds, SOP, Audits (internal and external for agents and distributors), CAPA, OEM, Training, Product  Registration including Product Launch, Product certification, Waste Segregation and  ISO 9001 and ISO 14001 certifications.
• Maintain fluid and excellent relationship with Competent Authorities, internal and external customers.
• Be focus on continuous improvement and participate in these activities across the European team.
• Ensure that systems/actions are put in place according to European regulations, country specific legislation and quality management certification requirements against the internal Stryker KPI objectives and targets.
• Technical and Scientific support.

Education

• Fluent in English & Spanish.
• Portuguese will be a plus.

Experience

• 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 14.001 and MDD vigilance and notification processes.

Competencies

• Good communication and team working skills.
• Analytical & customer service skills.
• Ability to prioritise and organise own workload.
• Ability to analyse data and statistics.