Quality, Regulatory & Risk Manager(m/w/x)

Description

You will safeguard patient safety by managing quality systems and risk strategies, ensuring every medical device meets rigorous global regulatory standards through expert documentation and auditing.

Requirements

• •Experience in QA, RA, and QMS
• •Experience in medical device risk management
• •Knowledge of MDR and ISO standards
• •Knowledge of QMS and support tools
• •Ability to mitigate regulatory risks
• •Experience supporting audits and investigations
• •Strong analytical and problem-solving skills

Tasks

• •Maintain and improve the Quality Management System
• •Ensure compliance with ISO 13485 and MDR
• •Develop SOPs and technical documentation
• •Provide technical writing and SME support
• •Manage medical device lifecycle risk assessments
• •Execute failure mode analyses and mitigation strategies
• •Assess nonconformance records and audit findings
• •Manage corrective and preventive actions
• •Coordinate internal and external supplier audits
• •Train stakeholders on quality and regulatory standards
• •Support product verification and validation activities
• •Oversee production controls and inspection activities
• •Collaborate on cross-functional product change management
• •Drive continuous improvement for patient safety
• •Promote a culture of regulatory compliance

Tools & Technologies

Benefits