Quality Assurance and Regulatory Compliance Specialist

OBJECTIVE AND MAIN TASK OF THE FUNCTION

Key role in supporting the implementation, maintenance, and improvement of the STAAR ISO 13485 and MDR 2017/745-based Quality Management System (QMS) at STAAR Spain. This position also provides regulatory support (as the back up) to ensure compliance with EU MDR 2017/745 and Spanish medical device regulations.

• Assist in designing, implementing, and maintaining the QMS
• Support the development and control of quality documentation, including SOPs, work instructions, forms, and records.
• Support qualification and management of suppliers providing service or products to STAAR Spain
• Support internal, supplier audits and prepare for external audits and inspections
• Lead, plan and ensure completion and documentation of trainings for STAAR Spain personnel on quality procedures and regulatory compliance

• Assist in designing, implementing, and maintaining the QMS according to ISO 13485 requirements and MDR 2017/745.
• Support the development, approval, control, and archiving of quality documentation, including SOPs, work instructions, forms, and records.
• Support qualification and management of suppliers providing products or services to STAAR Spain.
• Participate in gap analyses and help identify areas for process improvement.
• Support internal audits and prepare for external audits and inspections.
• Assist with risk management activities in line with ISO 14971 and ISO 13485.
• Lead, plan, and ensure completion and documentation of trainings for STAAR Spain personnel on quality procedures and regulatory compliance, including monitoring training effectiveness.
• Support the management and follow-up of CAPAs and non-conformities.
• Assist in complaint handling and vigilance reporting, including trend analysis.
• Support change control processes for products, processes, and documentation.
• Manage and maintain QA quarantine activities, ensuring proper segregation, documentation, and disposition of non-conforming or unverified products.
• Support management review preparation by providing quality and regulatory data, metrics, and improvement initiatives.
• Monitor and report on quality metrics and improvement initiatives to the Senior Manager of Quality Assurance.
• Ensure the QMS remains compliant with updates to ISO 13485, MDR 2017/745, and Spanish regulatory requirements.
• Other QA tasks, as assigned.

• Assist the Responsible Técnico in maintaining technical documentation and device files.
• Deputy PRRC.
• Support AEMPS registration and notifications for medical devices.
• Verify labelling and packaging comply with regulatory requirements.
• Assist with post-market surveillance (PMS) data collection and vigilance reporting processes.
• Stay informed of updates to EU MDR 2017/745, Spanish regulations, and other relevant guidance.
• Provide regulatory documentation and support for audits or inspections, as required.

• Assist the Responsible Técnico in collaboration with SPA Activa. Serves as the point of contact for the occupational health and safety provider in Spain, working in collaboration with the Human Resources department in Switzerland.
• Other tasks as assigned.

Education:

Certifications, formal training or courses in Quality Assurance, Regulatory Affairs, Medical Devices, Biomedical Technology, or Life Sciences. Certifications or formal training in ISO 13485, MDR 2017/745, Risk Management (ISO 14971), or Auditing. Bachelor’s or master’s degree in pharmacy, Biomedical Engineering, Biotechnology, or related field is a plus.

Special Knowledge:
Knowledge of Spanish medical device regulations, Knowledge of UDI, EUDAMED registration prefferred, Fluent in Spanish and English, written and spoken.

Personality:
Detail-oriented, analytical, and proactive, with strong organizational and communication skills; thrive in a collaborative environment, adaptable to change, and committed to maintaining the highest standards of quality and regulatory compliance.

Professional

Experience:

Minimum of 5 years of relevant experience in Quality Assurance and/or Regulatory Affairs within the medical device or pharmaceutical industry, demonstrating expertise in QMS implementation, audits, CAPA, and regulatory compliance.