Medical Device Quality Compliance Expert
Job Description:
• Lead quality management system activities for medical devices.
• Develop and implement compliance strategies.
• Conduct risk assessments and provide guidance on regulatory submissions.
• Collaborate with R&D, manufacturing, and regulatory affairs teams.
• Stay updated on regulatory trends affecting the medical device industry.
Requirements:
• 8 years of experience in quality assurance and regulatory compliance.
• Advanced degree preferred.
• Knowledge of ISO 13485, FDA QSR, and EU MDR.
• Experience leading quality management systems.
• Strong understanding of risk management principles.
• Excellent communication and interpersonal skills.
• Quality and regulatory certifications preferred.
Benefits:
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