Senior Compliance Specialist

Job Summary

A company is looking for a Senior Compliance Specialist.

Key Responsibilities

• Maintain compliance with regulatory standards and provide guidance during product development and operational changes
• Manage core Quality Management System (QMS) processes, including document control, complaint handling, and audit readiness
• Oversee complaint investigations and lead CAPA activities, ensuring continuous improvement across the organization

Required Qualifications

• Bachelor's degree in a life science, engineering, or related field, or equivalent experience
• Minimum 3 years of experience in quality assurance, regulatory, or compliance roles in medical devices or life sciences
• Strong knowledge of Good Clinical Practice (GCP) and international regulatory requirements
• Experience managing CAPAs and conducting internal/external GCP audits
• Proficient in Microsoft365