Quality and Regulatory Affairs Specialist

In this hybrid role, you contribute to post-market surveillance, vigilance activities, and regulatory compliance for life-saving medical devices. You will work with cross-functional teams to ensure timely, compliant handling of complaints and investigations, supporting audits and corrective actions. The role offers growth in regulatory and quality systems within a mission-driven environment. You will help protect patients while advancing regulatory knowledge and processes.

• flat hierarchies
• career development
• competitive salary and benefits package
• recognition programs
• collaborative and inclusive environment
• global opportunities

• Review complaints and assess reportability within timelines
• Manage complaint handling, including documentation and follow-up
• Review and approve investigations to support timely resolution
• Prepare and submit vigilance reports to authorities
• Maintain systems to monitor, track, and report complaints/adverse events
• Collaborate with investigators, teams, customers, and regulators for information collection
• Support audits, field actions, recalls, nonconformance investigations, and CAPA
• Contribute to development and maintenance of regulatory procedures and post-market surveillance processes

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or a related field
• Proficiency with computer-based systems and standard business software applications
• Fluent in English (written and spoken)

• Collaboration across cross-functional teams
• Attention to detail
• Effective communication
• Knowledge of 21 CFR Part 820 Quality System Regulation
• Knowledge of 21 CFR Part 803 Medical Device Reporting requirements
• Knowledge of European Medical Device Regulation (EU MDR) 2017/745