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.