Ensure compliance and product excellence with MIMOSA Diagnostics as a Senior Quality Assurance and Regulatory Affairs Specialist. Work hybrid from Toronto to drive improvements in quality standards.
MIMOSA is committed to compassionate care through innovative solutions and seeks a Senior Quality Assurance/Regulatory Affairs Specialist. This role plays a crucial part in maintaining compliance with regulatory standards governing medical devices. A deep understanding of quality management systems in the medical industry is essential for facilitating audits and collaboration on quality issues.
Key Responsibilities:
• Develop quality assurance strategies to meet compliance needs
• Perform internal audits and regulatory inspections
• Prepare regulatory documentation for Health Canada and FDA
• Address regulatory compliance issues with cross-functional teams
• Lead product quality investigations and corrective actions
Requirements:
• Bachelor’s degree in Science or Engineering
• At least 3 years in quality assurance, medical devices preferred
• In-depth knowledge of ISO 13485:2016 and regulations
• Robust communication and analytical capabilities
• Certification in quality assurance is beneficial
Contribute to MIMOSA’s mission of empowering quality healthcare by ensuring compliance and excellence in product offerings.
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