Sr Compliance Specialist

Senior Compliance Specialist role at Medtronic focused on quality systems oversight and regulatory compliance for medical device manufacturing. Responsible for investigations, corrective actions, audit coordination, and ensuring adherence to FDA and international regulations across operating units.

Responsibilities

• Lead investigations, root cause analyses, and corrective/preventive action execution
• Provide quality system support and guidance to ensure FDA and international regulatory compliance
• Coordinate and prepare internal and external audits per regulatory standards
• Support EU Surgical Operating Unit entities with quality oversight and process development
• Perform trend analyses and report compliance observations to leadership

Requirements

• Bachelor's degree required; advanced degree with 4+ years experience acceptable
• Minimum 6 years relevant quality and regulatory compliance experience
• Comprehensive knowledge of FDA, GMP, QSR, ISO 13485, and MDSAP requirements
• Proficiency with data analysis tools and strong problem-solving skills
• Outstanding written and oral communication abilities
• Ability to manage multiple critical projects and make independent decisions